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Throughout the fall, unusual white blobs have been washing ashore on beaches in eastern Newfoundland. A Memorial University chemist says the substance is a type of pollution that shouldn't have been in the ocean in the first place.

The U.K. based aerospace company, Space Solar, plans to launch its space-based solar power plant by 2030 to deliver clean energy to Iceland, which is already a renewable-energy powerhouse.

Sibert and Red Cloud, black-footed ferret siblings at the Smithsonian’s National Zoo and Conservation Biology Institute, are the first members of an endangered species born to a cloned animal.

2024 has been a rough year for Sonos. The company’s would-be triumphant entry into the crowded headphones market was overshadowed by a disastrous app redesign. In the fallout of the botched software update, the company decided to delay products that were ready to be shipped to give itself more time to right the course. Consumer trust eroded, and people who already owned Sonos gear were living in a cycle of constant frustration.

Thanks to a number of rumors, we already knew that one of the pending product releases was the Arc Ultra ($999). A few weeks ago the company decided not to wait any longer to reveal it. While the design is mostly unchanged from the Arc that debuted in 2020, there are several key changes on the inside that make this a better all-in-one solution for people who don’t want to add more speakers to their living room setup. Sonos is promising better bass performance thanks to new speaker tech that’s debuting in the Arc Ultra, but just how good can it be?

Design

The refined design of the original Arc was a massive upgrade from that of the Playbar, and showed a progression from Sonos’ compact Beam soundbar. Honestly, the aesthetic is pretty timeless, in my opinion, and it’s a look that should age well for years to come. That said, it makes sense that Sonos would keep the design for the Arc Ultra, only making some minor changes to the exterior.

The Arc Ultra still comes in both black and white options, allowing you to choose what looks best in your living room or home theater. Sonos updated the controls to mirror what’s available on the newer Era 100 and Era 300 speakers, moving them to a top-facing bar at the back. There’s a volume slider on the right with play/pause and skip controls in the center. On the left side, Sonos gives you a microphone control so you can mute the built-in mics as needed.

And that’s really it in terms of design changes that you can see. The Arc Ultra is slightly shorter height-wise than the Arc, and it’s a little wider than its predecessor. Neither of which make a huge difference, and they won’t drastically change how you position the speaker beneath your TV.

Sonos

Inside, Sonos has re-engineered the Arc Ultra to improve audio performance. The biggest piece of this overhaul is the new Sound Motion woofer that enables better bass performance before you add a standalone wireless sub. The achievement here, thanks to the acquisition of audio company Mayht, is that the new component lays flat, taking up less room than a traditional cone-shaped woofer. The Sound Motion driver also helps deliver increased clarity and depth, on top of doubling the bass output of the original Arc.

Sonos redesigned the entire acoustic architecture of the Arc Ultra during the process of adding the Sound Motion woofer. The soundbar now houses three more drivers than the arc, a list that includes seven tweeters (two of which are upfiring), six mid-range drivers (midwoofers, as Sonos calls them) and the aforementioned woofer for a total of 14. The company also employs 15 Class-D digital amplifiers along with far-field mics for tuning and voice control.

There’s still only a single HDMI (eARC) port, which allows most modern TVs the ability to control the soundbar’s volume and mute options from your TV remote. Moreover, the Arc Ultra is compatible with Wi-Fi 6 and newly-added Bluetooth 5.3 connectivity allows you to stream from any device. And of course, AirPlay 2 is still on the spec sheet. One last thing I’ll mention here is that the Arc Ultra doesn’t ship with an optical adapter if you prefer that connection. The company will sell you one for $25.

Software and features

Since the Arc Ultra is a Sonos product, there are a lot of core features that are the same as they are on the company’s other devices. You can use the soundbar as part of a multiroom setup and Trueplay tuning is here to adjust the audio to the acoustics of the room. There’s still an adjustable EQ with options for bass, treble and loudness and a Night Sound mode makes things less boomy when someone in your house may be trying to work or sleep.

While Trueplay will give you the best sound customization for the sonic characteristics of your living room, Sonos is enabling a Quick Tune feature for the first time on the Arc Ultra. Here, the soundbar will use its internal mics, as opposed to your phone, to offer a certain degree of improvement. The company says it wanted to give people the option of something quicker than Trueplay, although the full-fledged tuning process doesn’t take very long at all.

Speech Enhancement has been a handy feature on Sonos soundbars for a while, giving you the ability to improve dialog clarity as needed. Before now, it was an all-or-nothing feature, but on the Arc Ultra, the company introduced three levels of speech boost to give you more options to better suit your needs. This means the soundbar can help you hear clearly over background noise or simply follow along better by elevating dialog above the rest of the soundtrack mix.

Billy Steele for Engadget

The trademark feature of Sonos’ Ace headphones is the ability to beam the audio from a compatible soundbar to the cans for a private home theater. That TV Audio Swap tool is available on the Arc Ultra, so you can instantly send the sound to the headphones with the press of a button. In fact, Sonos bundles the Arc Ultra and Ace headphones in a $1,373 set. What’s more, the Ace supports spatial audio with dynamic head tracking, so you can count on immersive sound even when you’re employing it on an individual basis.

Despite all of the problems that Sonos has had with its app, some of which it's still working to resolve, I didn't encounter any issues during my testing. The software crashed on me once when the Trueplay tuning process completed, but everything had already run its course and I didn’t have to repeat it. Other than that, the app has worked reliably over the last week while I’ve been putting the Arc Ultra through its paces. Most importantly, the software is stable and the full suite of controls for the new soundbar is available at launch.

Sound performance

The original Arc already sounded great, so Sonos really had its work cut out for it to further improve the audio quality for the Arc Ultra. Thanks to the improved bass of the Sound Motion tech, a change that also takes up less space, the company says it had the ability to then overhaul the mid-range and high-frequency components as well. By using multiple sizes of mid-range drivers and tweeters, Sonos was able to tweak the speaker positioning inside of the soundbar for improved projection and more immersive sound.

In addition to the enhanced bass performance, the second thing that was immediately apparent on the Arc Ultra was those improvements to the dimensional sound. Whether it was a quidditch match in a Harry Potter movie or zooming F1 cars in Drive to Survive, the soundbar now has better directional, immersive sound than its predecessor. Sonos says the Arc Ultra now renders Dolby Atmos content in a 9.1.4-channel setup, versus 5.0.2 with the Arc, which further contributes to the enveloping audio. Interestingly, I haven’t seen any of the competition claim four up-firing channels from the soundbar like Sonos does here (those that do are usually accounting for up-firing drivers in the rear speakers). You can really hear the difference from the second you fire up the Arc Ultra, and the effect is consistent across content sources.

Billy Steele for Engadget

The increased bass performance makes the Arc Ultra a much better speaker for music without a separate subwoofer. You won’t get the bombastic low-end tone the newly updated Sonos Sub 4 can produce, but there’s enough from the soundbar to give Kaytranada’s Timeless, Phantogram’s Memory of a Day and Bilmuri’s American Motor Sports plenty of booming backbone when a track demands it. There’s also still the trademark Sonos clarity I’ve come to expect over the years, which means finer details like the texture of synths, layered guitars and the nuance of acoustic instruments cut through the mix cleanly.

And speaking of clarity, the company’s new Speech Enhancement settings are also a big improvement. Being able to select how much of a boost this feature offered depending on either my needs right then or based on the overall tuning of the content is really nice. It allowed me to max out the dialog when watching movies after my toddler was asleep so that speech didn’t suffer when sound effects were louder during intense scenes of The Hobbit: An Unexpected Journey.

The competition

There’s no doubt the Arc Ultra packs in deeper, more immersive sound than its predecessor, but some people will still want a more robust setup to wring every ounce of audio out of a Sonos living room setup. The high-end choice for this is what Sonos calls the Ultimate Immersive Set, which includes the Arc Ultra, two Era 300s and the Sub 4. Right now, that will cost you $2,561. For something less expensive, you can get the Arc Ultra and the new Sub 4 (normally $799) for $1,708 (Premium Entertainment Set). And therein lies the biggest problem with Sonos soundbars: expanding your living room setup to get the most immersive experience gets very pricey very quickly when the centerpiece is already $999.

If you can live without all the conveniences of Sonos products, you can get an all-in-one package from Samsung for $1,500. With the Q990D, you’ll get the soundbar, two rear speakers and a wireless subwoofer in the same box. The setup offers 11.1.4 audio for excellent Atmos sound, thanks in part to up-firing drivers in the rear speakers. Samsung offers a host of handy features, from Q-Symphony audio with TV speakers, SpaceFit Sound Pro room calibration, Adaptive Sound audio enhancement, a dedicated gaming mode and more. The Q990D remains my top pick for the best soundbars for a lot of reasons, a key one being everything you could need comes in one all-inclusive package.

Wrap-up

The Arc Ultra is an obvious improvement over the Arc in the sonic department. New technology delivers on its promise to boost bass, clarity and immersive before you start adding extra components. Expanded features like Speech Enhancements and a quick-tune option offer new tools for dialing in the sound, while the stock Sonos experience remains intact. And thankfully, that includes an app that’s more stable than it was a few months ago. The Arc Ultra is still pricey at $999, but it exhibits a lot more sonic prowess than its predecessor for only $100 more.

This article originally appeared on Engadget at https://www.engadget.com/audio/speakers/sonos-arc-ultra-review-new-tech-powers-a-big-audio-upgrade-130011149.html?src=rss

Today's edition of things I suddenly really really need comes courtesy of LG Display. The company has developed what it claims to be the first display capable of stretching up to 50 percent. The screen is able to expand from 12 inches to 18 inches and can bend, twist and stretch — basically the Bop It of the tech world. LG Display unveiled another model in 2022, which stretched from 12 inches to 14 inches — about 20 percent longer.

 So, how did it go from 20 percent to 50 percent stretch capabilities? According to the company, "By applying a number of new technologies, such as improving the properties of a special silicon material substrate used in contact lenses and developing a new wiring design structure, LG Display improved the panel’s stretchability and flexibility, exceeding the original national project’s target of 20 percent elongation."

The free-form screen technology, as LG Display calls it, has full red, green and blue color with a resolution of 100ppi. The display also uses a micro-LED light source smaller than 40 micrometers, allowing the screen to be stretched over 10,000 times. The company claims it should still have high quality images even if it undergoes an external shock or is in more extreme temperatures than normal. 

Unfortunately for me (though certainly good for my wallet), the stretchable display is currently just a prototype. However, it could be used for flexible items like clothing, car panels and more in the future. 

This article originally appeared on Engadget at https://www.engadget.com/lgs-new-display-stretches-from-12-to-18-inches-124504018.html?src=rss

NVIDIA has been testing a single app that merges the GeForce Experience and Control Panel over the past year. After rolling out several betas to make sure it works as intended, the company has officially launched the NVIDIA application, which is now available to download for users with its GPUs in their PCs and laptops. 

The company says the app is meant to make it easy to keep their NVIDIA Studio and GeForce Game Ready drivers updated and to give users quick access to its latest programs. In its home screen, users will find a prominently displayed section that will lead them to the latest driver downloads, as well as sections that will take them to other NVIDIA applications. At the bottom, they'll find a Library section showing their most recently opened games and programs that they can launch from there. 

Since it's supposed to provide a unified experience, users will be able to fine-tune the settings for their games and programs from within the app. Users will be able to access Optimal Playable Settings with relevant Control Panel options, and they'll be able to configure their displays, enable G-SYNC, enhance videos with AI and fine-tune their GPU's performance from within its interface. 

NVIDIA explains that it designed the unified application to be 50 percent more responsive than the GeForce Experience. It also installs in half the time. It's also worth noting that app will introduce a redesigned in-game overlay that simplifies access to gameplay recording tools capable of capturing video in 4K at 120 FPS, as well as AI-powered filters for those with RTX GPUs. They'll then be able to view their screenshots and new videos in the app's Gallery. 

This article originally appeared on Engadget at https://www.engadget.com/computing/nvidias-new-all-in-one-pc-app-launches-out-of-beta-today-140040945.html?src=rss

President-elect Donald Trump has named Elon Musk as the leader of a new “Department of Government Efficiency," that will “dismantle Government Bureaucracy, slash excess regulations, cut wasteful expenditures, and restructure Federal Agencies.” The Tesla CEO and owner of X will spearhead the effort along with former presidential candidate Vivek Ramaswamy, Trump announced in a statement on Truth Social.

The scope of the role isn’t exactly clear. Trump’s press release said that “the Department of Government Efficiency will provide advice and guidance from outside of Government, and will partner with the White House and Office of Management & Budget to drive large scale structural reform, and create an entrepreneurial approach to Government never seen before.” It also stated that “their work will conclude no later than July 4, 2026.”

Musk shared the news on X, but didn’t indicate how the role might impact his obligations at his various other companies. Musk, who poured millions of dollars into Super Pac boosting Trump’s campaign, has previously talked about his desire to work with Trump to cut government spending. He did, however, joke about potential "merch" for the operation. "Republican politicians have dreamed about the objectives of 'DOGE' for a very long time," Trump's statement said. 

This article originally appeared on Engadget at https://www.engadget.com/big-tech/elon-musk-will-lead-a-new-department-of-government-efficiency-donald-trump-says-015521217.html?src=rss

CBC has announced it's investing more in local and regional news. The coverage includes up to 25 journalists in more than a dozen communities and four new daily local podcasts.

KOROROIT MP Marlene Kairouz will become Victoria’s new minister for consumer affairs, gambling and liquor regulation.

The Arctic territory hopes that three new airports will pave the way for direct flights from the US and Europe.

The office of the Additional Director General of Foreign Trade (CLA DGFT) has announced an Export Obligation Discharge Certificate (EODC) Camp scheduled from November 11 to 22, 2024. The camp is

Indian pharma and biotech companies are confident that under the new US President Donald Trump, its strengths in high quality generics manufacture and export will continue to command respect. This view is

The recent amendments brought by the Union Ministry of Ayush to the Drugs and Cosmetics Rules, 1945 are significant, as they introduce new regulatory requirements for the manufacturing and sale of traditional

The centrally sponsored scheme for strengthening of medical devices industry (SMDI), launched by the Central government last week, was widely welcomed by the medical devices industry in the country.

Placon, an innovator in the medical packaging market, announced the release of a new stock line of BargerGard TPU pouches and tip protectors.

The discovery of a new prime number highlights the rising price of mathematical gold

The Martian new year arrives with the Red Planet’s vernal equinox. Explaining why requires a deep dive into celestial mechanics and Earth’s calendrical history

Arriving in two boxes reminiscent of Apple product packaging – one for the chest piece (the part that contacts the body), and another for the detachable earpiece (tubes + ear tips) – the CORE 500 is clearly an upgrade from the Eko DUO stethoscope. Similar to its predecessor, the CORE 500 can be used with […]

Autumn is here! Curl up with your favorite pumpkin-spiced blog and savor these acorns that we’ve squirrelled away for you:

• Johnson & Johnson Innovative Medicines gives a peek inside its $43 billion gross-to-net bubble

• Optum Rx joins the private label biosimilar bandwagon

• Biosimilars boom for provider-administered drugs

• Fresh evidence of how copay accumulators hurt patients

Plus, words of wisdom from Cencora's soon-to-be-former CEO Steve Collis.

P.S. Join my more than 58,000 LinkedIn followers for daily links to neat stuff along with thoughtful and provocative commentary from the DCI community.

There’s still time to request an invite to the inaugural Drug Channels Leadership Forum. Attendance will be highly limited. We have already begun extending invitations, so apply now to be considered. Click here to view the full agenda.

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Drug Channel Institute is pleased to announce The Drug Channels 2025 Video Webinar Series.

Join Dr. Adam J. Fein for three live video webinars during 2025. These live, interactive events will be broadcast via Zoom from the Drug Channels Video studio in beautiful downtown Philadelphia.

During these events, Dr. Fein will address the latest issues confronting the U.S. drug channel. Topics will be determined based on what’s happening—trends, policy changes, company announcements, and more. He’ll share DCI’s latest market data to help you stay on top of new developments. You will be able to use these events as both a capstone of your current learning and a touchpoint for the future.

The three events are scheduled for 12:00 p.m. to 1:30 p.m. ET on the following dates:

• April 4, 2025

• June 20, 2025

• December 12, 2025 (Drug Channels Outlook 2026)

For 2025, we are offering a Corporate Pricing option that will allow larger organizations to register hundreds of colleagues for one fixed price. Please contact Paula Fein (paula@drugchannels.net) for details.

Read on for full details on pricing, including substantial discounts for multiple sites.

P.S. If you're not familiar with our webinars, click here to watch brief excerpts from our video webinars.
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Eeek! It's time for Drug Channels’ Halloween roundup of terrifying tales to share with your ghoulish fiends. This month’s tricks and treats:

• Spooky! Blue Shield of California frightens away the gross-to-net bubble with its Humira biosimilar strategy

• Vampiric! Prior authorization sinks its fangs into providers’ time

• Wicked! How the IRA will put a stake through specialty physician practices

• Eerie! Google’s monstrous AI podcasts leave me petrified

• Zoinks! Join the vampire hunters at Drug Channels Institute

Plus, Dr. Glaucomflecken tells us a frightening tale of copayments.

P.S. Stretch out your arms and join the ever-growing zombie horde who shamble after me on LinkedIn. You’ll find my ghostly rantings along with commentary from the undead hordes in the DCI community.
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Adam J. Fein, Ph.D., president of Drug Channels Institute (DCI) and the author of Drug Channels, invites you to join him for DCI’s new live video webinar:

Friday, December 13, 2024,

from 12:00 p.m. to 1:30 p.m. ET

This post describes the event and explains how to purchase a registration. (Or, just click here to order.) The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia.

This event is part of The Drug Channels 2024 Video Webinar Series. (Please note that our December 2024 webinar is *not* included with next year’s 2025 Video Webinar Series.)

WHAT YOU WILL LEARN

Join Dr. Fein as he helps you and your team get ready for 2025 by outlining key issues and uncertainties that will surely affect your planning. This event can be both a capstone of your annual learning and a touchpoint for the future. DCI’s Outlook webinars have proven to be reliable and informative guides to crucial aspects of the ever-evolving healthcare industry.

During the event, Dr. Fein will share his latest thinking and projections on a wide range of topics, including:

• Latest predictions for the Inflation Reduction Act

• Expectations for the Medicare Part D market in 2025 and beyond

• Update on 340B Drug Pricing Program’s controversies

• Impact of the new Trump administration and Congress on the drug channel

• Vertical integration and consolidation trends—and prospects for dis-integration and de-consolidation

• The state of biosimilar markets

• What’s next for PBMs’ private label products and GPOs

• Retail pharmacy’s future

• Prospects for direct-to-patient channels

• What’s ahead for discount cards and cash-pay pharmacies

• The outlook for state and federal legislation on PBMs and the drug channel

• Gross-to-net bubble developments

• And much more!

PLUS: During the webinar, Dr. Fein will give participants an opportunity to unmute themselves and ask live questions. The webinar will last at least 90 minutes to accommodate audience questions.

As always, Dr. Fein will clearly distinguish his opinions and interpretations from the objective facts and data. He will draw from exclusive information found in DCI's economic reports .

Read on for full details on pricing and registration.
Read more »

The U.S. Food and Drug Administration posted a video:

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

I am pleased to announce the availability of on-demand training about FDA's regulation of advertising and promotion. So, you are now able to learn about the wonderful world of FDA ad-promo from the comfort of your home, office, or campsite. 

Note to readers: After a period of inactivity CardioBrief is coming back, but with some big differences. This website, CardioBrief.Org, will remain my personal website. A new website, CVCTCardiobrief.com, will be the new home for my “professional” blogging activities. To develop this website I have joined forces with the global CVCT Forum. I look forward to...

Click here to continue reading...

Fake news didn’t just become a problem because of Trump, or the pandemic. It’s been around for a long while. The problem can’t begin to be solved unless the medical and scientific community accepts that it has an absolute responsibility to aggressively debunk fake news and defend and support scientific principles. Click here to read...

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<p>In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications&nbsp;of registered pharmaceutical products and natural health supplements (TMHS).</p>

A new type of drug that targets chemotherapy directly to cancer cells reduces the risk of death from the most common type of bladder cancer by 30%, a phase III trial in the New England Journal of Medicine has suggested.

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Ever wondered what goes into diligencing a new idea, program, company, or platform? While each diligence is unique and every investor will have

The post Deconstructing the Diligence Process: An Approach to Vetting New Product Theses appeared first on LifeSciVC.

By Jonathan Montagu, CEO of HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC As Boston’s weather has started its turn from the frigid darkness that is a northeast winter to the longer days and lighter conditions

The post Has Spring Sprouted New Growth in Immuno-Oncology? appeared first on LifeSciVC.

PDUFA V commitments signal a strong commitment to tolerance of open debate in the face of uncertainty.

I can admit to a rather powerful lack of enthusiasm when reading about interpersonal squabbles. It’s even worse in the scientific world: when I read about debates getting mired in personal attacks I tend to simply stop reading and move on to something else.

However, the really interesting part of this week’s meeting of an FDA joint Advisory Committee to discuss the controversial diabetes drug Avandia – at least in the sense of likely long-term impact – is not the scientific question under discussion, but the surfacing and handling of the raging interpersonal battle going on right now inside the Division of Cardiovascular and Renal Products. So I'll have to swallow my distaste and follow along with the drama.

Two words that make us mistrust Duke:  Anil Potti Christian Laettner

Not that the scientific question at hand – does Avandia pose significant heart risks? – isn't interesting. It is. But if there’s one thing that everyone seems to agree on, it’s that we don’t have good data on the topic. Despite the re-adjudication of RECORD, no one trusts its design (and, ironically, the one trial with a design to rigorously answer the question was halted after intense pressure, despite an AdComm recommendation that it continue).  And no one seems particularly enthused about changing the current status of Avandia: in all likelihood it will continue to be permitted to be marketed under heavy restrictions. Rather than changing the future of diabetes, I suspect the committee will be content to let us slog along the same mucky trail.

The really interesting question, that will potentially impact CDER for years to come, is how it can function with frothing, open dissent among its staffers. As has been widely reported, FDA reviewer Tom Marciniak has written a rather wild and vitriolic assessment of the RECORD trial, excoriating most everyone involved. In a particularly stunning passage, Marciniak appears to claim that the entire output of anyone working at Duke University cannot be trusted because of the fraud committed by Duke cancer researcher Anil Potti:

I would have thought that the two words “Anil Potti” are sufficient for convincing anyone that Duke University is a poor choice for a contractor whose task it is to confirm the integrity of scientific research. 

(One wonders how far Marciniak is willing to take his guilt-by-association theme. Are the words “Cheng Yi Liang” sufficient to convince us that all FDA employees, including Marciniak, are poor choices for deciding matter relating to publicly-traded companies? Should I not comment on government activities because I’m a resident of Illinois (my two words: “Rod Blagojevich”)?)

Rather than censoring or reprimanding Marciniak, his supervisors have taken the extraordinary step of letting him publicly air his criticisms, and then they have in turn publicly criticized his methods and approach.

I have been unable to think of a similar situation at any regulatory agency. The tolerance for dissent being displayed by FDA is, I believe, completely unprecedented.

And that’s the cliffhanger for me: can the FDA’s commitment to transparency extend so far as to accommodate public disagreements about its own approval decisions? Can it do so even when the disagreements take an extremely nasty and inappropriate tone?

• Rather than considering that open debate is a good thing, will journalists jump on the drama and portray agency leadership as weak and indecisive?
• Will the usual suspects in Congress be able to exploit this disagreement for their own political gain? How many House subcommittees will be summoning Janet Woodcock in the coming weeks?

I think what Bob Temple and Norman Stockbridge are doing is a tremendous experiment in open government. If they can pull it off, it could force other agencies to radically rethink how they go about crafting and implementing regulations. However, I also worry that it is politically simply not a viable approach, and that the agency will ultimately be seriously hurt by attacks from the media and legislators.

Where is this coming from?

As part of its recent PDUFA V commitment, the FDA put out a fascinating draft document, Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. It didn't get a lot of attention when first published back in February (few FDA documents do). However, it lays out a rather bold vision for how the FDA can acknowledge the existence of uncertainty in its evaluation of new drugs. Its proposed structure even envisions an open and honest accounting of divergent interpretations of data:

When they're frothing at the mouth, even Atticus doesn't let them publish a review

A framework for benefit-risk decision-making that summarizes the relevant facts, uncertainties, and key areas of judgment, and clearly explains how these factors influence a regulatory decision, can greatly inform and clarify the regulatory discussion. Such a framework can provide transparency regarding the basis of conflicting recommendations made by different parties using the same information.

(Emphasis mine.)

Of course, the structured framework here is designed to reflect rational disagreement. Marciniak’s scattershot insults are in many ways a terrible first case for trying out a new level of transparency.

The draft framework notes that safety issues, like Avandia, are some of the major areas of uncertainty in the regulatory process. Contrast this vision of coolly and systematically addressing uncertainties with the sad reality of Marciniak’s attack:

In contrast to the prospective and highly planned studies of effectiveness, safety findings emerge from a wide range of sources, including spontaneous adverse event reports, epidemiology studies, meta-analyses of controlled trials, or in some cases from randomized, controlled trials. However, even controlled trials, where the evidence of an effect is generally most persuasive, can sometimes provide contradictory and inconsistent findings on safety as the analyses are in many cases not planned and often reflect multiple testing. A systematic approach that specifies the sources of evidence, the strength of each piece of evidence, and draws conclusions that explain how the uncertainty weighed on the decision, can lead to more explicit communication of regulatory decisions. We anticipate that this work will continue beyond FY 2013.

I hope that work will continue beyond 2013. Thoughtful, open discussions of real uncertainties are one of the most worthwhile goals FDA can aspire to, even if it means having to learn how to do so without letting the Marciniaks of the world scuttle the whole endeavor.

Participant reported relief from chronic low back pain and reduced need for pain-relief medications.

This article is part of our exclusive IEEE Journal Watch series in partnership with IEEE Xplore.

Sea turtles are remarkable creatures for a number of reasons, including the way they hear underwater—not through openings in the form of ears, but by detecting vibrations directly through the skin covering their auditory system. Inspired by this ability to detect sound through skin, researchers in China have created a heart-monitoring system, which initial tests in humans suggest may be a viable for monitoring heartbeats.

A key way in which doctors monitor heart health involves “listening” to the heartbeat, either using a stethoscope or more sophisticated technology, like echocardiograms. However, these approaches require a visit to a specialist, and so researchers have been keen to develop alternative, lower cost solutions that people can use at home, which could also allow for more frequent testing and monitoring.

Junbin Zang, a lecturer at the North University of China, and his colleagues specialize in creating heart-monitoring technologies. Their interest was piqued when they learned about the inner workings of the sea turtle’s auditory system, which is able to detect low-frequency signals, especially in the 300- to 400-hertz range.

“Heart sounds are also low-frequency signals, so the low-frequency characteristics of the sea turtle’s ear have provided us with great inspiration,” explains Zang.

At a glance, it looks like turtles don’t have ears. Their auditory system instead lies under a layer of skin and fat, through which it picks up vibrations. As with humans, a small bone in the ear vibrates as sounds hit it, and as it oscillates, those pulses are converted to electrical signals that are sent to the brain for processing and interpretation.

iStock

But sea turtles have a unique, slender T-shaped conduit that encapsulates their ear bones, restricting the movement of the similarly T-shaped ear bones to only vibrate in a perpendicular manner. This design provides their auditory system with high sensitivity to vibrations.

Zang and his colleagues set out to create a heart monitoring system with similar features. They created a T-shaped heart-sound sensor that imitates the ear bones of sea turtles using a tiny MEMS cantilever beam sensor. As sound hits the sensor, the vibrations cause deformations in its beam, and the fluctuations in the voltage resistance are then translated into electrical signals.

The researchers first tested the sensor’s ability to detect sound in lab tests, and then tested the sensor’s ability to monitor heartbeats in two human volunteers in their early 20s. The results, described in a study published 1 April in IEEE Sensors Journal, show that the sensor can effectively detect the two phases of a heartbeat.

“The sensor exhibits excellent vibration characteristics,” Zang says, noting that it has a higher vibration sensitivity compared to other accelerometers on the market.

However, the sensor currently picks up a significant amount of background noise, which Zang says his team plans to address in future work. Ultimately, they are interested in integrating this novel bioinspired sensor into devices they have previously created—including portable handheld and wearable versions, and a relatively larger version for use in hospitals—for the simultaneous detection of electrocardiogram and phonocardiogram signals.

This article appears in the July 2024 print issue as “Sea Turtles Inspire Heart-Monitor Design.”

The future of an innovative retinal implant and dozens of its users just got brighter, after Science, a bioelectronics startup run by Neuralink’s cofounder, Max Hodak, acquired Pixium’s technology at the last minute.

Pixium Vision, whose Prima system to tackle vision loss is implanted in 47 people across Europe and the United States, was in danger of disappearing completely until Science stepped in to buy the French company’s assets in April, for an undisclosed amount.

Pixium has been developing Prima for a decade, building on work by Daniel Palanker, a professor of ophthalmology at Stanford University. The 2-by-2-millimeter square implant is surgically implanted under the retina, where it turns infrared data from camera-equipped glasses into pulses of electricity. These replace signals generated by photoreceptor rods and cones, which are damaged in people suffering from age-related macular degeneration (AMD).

Early feasibility studies in the E.U. and the United States suggested Prima was safe and potentially effective, but Pixium ran out of money last November before the final results of a larger, multiyear pivotal trial in Europe.

“It’s very important to us to avoid another debacle like Argus II.”

With the financial and legal clock ticking down, the trial data finally arrived in March this year. “And the results from that were just pretty stunning,” says Max Hodak, Science’s founder and CEO, in his first interview since the acquisition.

Although neither Pixium nor Science has yet released the full dataset, Hodak shared with IEEE Spectrum videos of three people using Prima, each of them previously unable to read or recognize faces due to AMD. The videos show them slowly but fluently reading a hardback book, filling in a crossword puzzle, and playing cards.

“This is legit ‘form vision’ that I don’t think any device has ever done,” says Hodak. Form vision is the ability to recognize visual elements as parts of a larger object. “It’s this type of data that convinced us. And from there we were like, this should get to patients.”

As well as buying the Prima technology, Hodak says that Science will hire the majority of Pixium’s 35 engineering and regulatory staff, in a push to get the technology approved in Europe as quickly as possible.

The Prima implant receives visual data and is powered by near-infrared signals beamed from special spectacles.Pixium

Another priority is supporting existing Prima patients, says Lloyd Diamond, Pixium’s outgoing CEO. “It’s very important to us to avoid another debacle like Argus II,” he says, referring to another retinal implant whose manufacturer went out of business in 2022, leaving users literally in the dark.

Diamond is excited to be working with Science, which is based in Silicon Valley with a chip foundry in North Carolina. “They have a very deep workforce in software development, in electronic development, and in biologic research,” he says. “And there are probably only a few foundries in the world that could manufacture an implant such as ours. Being able to internalize part of that process is a very big advantage.”

Hodak hopes that a first-generation Prima product could quickly be upgraded with a wide-angle camera and the latest electronics. “We think that there’s one straight shrink, where we’ll move to smaller pixels and get higher visual acuity,” he says. “After that, we’ll probably move to a 3D electrode design, where we’ll be able to get closer to single-cell resolution.” That could deliver even sharper artificial vision.

In parallel, Science will continue Pixium’s discussions with the FDA in the United States about advancing a clinical trial there.

The success of Prima is critical, says Hodak, who started Science in 2021 after leaving Neuralink, a brain-computer interface company he cofounded with Elon Musk. “Elon can do whatever he wants for as long as he wants, but we need something that can finance future development,” he says. “Prima is big enough in terms of impact to patients and society that it is capable of helping us finance the rest of our ambitions.”

These include a next-generation Prima device, which Hodak says he is already talking about with Palanker, and a second visual prosthesis, currently called the Science Eye. This will tackle retinitis pigmentosa, a condition affecting peripheral vision—the same condition targeted by Second Sight’s ill-fated Argus II device.

“The Argus II just didn’t work that well,” says Hodak. “In the end, it was a pure bridge to nowhere.” Like the Argus II and Prima, the Science Eye relies on camera glasses and an implant, but with the addition of optogenetic therapy. This uses a genetically engineered virus to deliver a gene to specific optic nerve cells in the retina, making them light-sensitive at a particular wavelength. A tiny implanted display with a resolution sharper than an iPhone screen then enables fine control over the newly sensitized cells.

That system is still undergoing animal trials, but Hodak is almost ready to pull the trigger on its first human clinical studies, likely in Australia and New Zealand.

“In the long term, I think precision optogenetics will be more powerful than Prima’s electrical stimulation,” he says. “But we’re agnostic about which approach works to restore vision.”

One thing he does believe vehemently, unlike Musk, is that the retina is the best place to put an implant. Neuralink and Cortigent (the successor company of Second Sight) are both working on prosthetics that target the brain’s visual cortex.

“There’s a lot that you can do in cortex, but vision is not one of them,” says Hodak. He thinks the visual cortex is too complex, too distributed, and too difficult to access surgically to be useful.

“As long as the optic nerve is intact, the retina is the ideal place to think about restoring vision to the brain,” he says. “This is all a question of effect size. If someone has been in darkness for a decade, with no light, no perception, and you can give them any type of visual stimulus, they’re going to be into it. The Pixium patients can intuitively read, and that was really what convinced us that this was worth picking up and pursuing.”

UPDATE 31 OCTOBER 2024: No. 1 no longer. The would-have-been groundbreaking study published in Nature Communications by Amit Goyal et al. claiming the world’s highest-performing high-temperature superconducting wires yet has been retracted by the authors.

The journal’s editorial statement that now accompanies the paper says that after publication, an error in the calculation of the reported performance was identified. All of the study’s authors agreed with the retraction.

The researchers were first alerted to the issue by Evgeny Talantsev at the Mikheev Institute of Metal Physics in Ekaterinburg, Russia, and Jeffery Tallon at the Victoria University of Wellington in New Zealand. In a 2015 study, the two researchers had suggested upper limits for thin-film superconductors, and Tallon notes follow-up papers showed these limits held for more than 100 known superconductors. “The Goyal paper claimed current densities 2.5 times higher, so it was immediately obvious to us that there was a problem here,” he says.

Upon request, Goyal and his colleagues “very kindly agreed to release their raw data and did so quickly,” Tallon says. He and Talantsev discovered a mistake in the conversion of magnetization units.

“Most people who had been in the game for a long time would be fully conversant with the units conversion because the instruments all deliver magnetic data in [centimeter-gram-second] gaussian units, so they always have to be converted to [the International System of Units],” Tallon says. “It has always been a little tricky, but students are asked to take great care and check their numbers against other reports to see if they agree.”

In a statement, Goyal notes he and his colleagues “intend to continue to push the field forward” by continuing to explore ways to enhance wire performance using nanostructural modifications. —Charles Q. Choi

Original article from 17 August, 2024 follows:

Superconductors have for decades spurred dreams of extraordinary technological breakthroughs, but many practical applications for them have remained out of reach. Now a new study reveals what may be the world’s highest-performing high-temperature superconducting wires yet, ones that carry 50 percent as much current as the previous record-holder. Scientists add this advance was achieved without increased costs or complexity to how superconducting wires are currently made.

Superconductors conduct electricity with zero resistance. Classic superconductors work only at super-cold temperatures below 30 degrees Kelvin. In contrast, high-temperature superconductors can operate at temperatures above 77 K, which means they can be cooled to superconductivity using comparatively inexpensive and less burdensome cryogenics built around liquid nitrogen coolant.

Regular electrical conductors all resist electron flow to some degree, resulting in wasted energy. The fact that superconductors conduct electricity without dissipating energy has long lead to dreams of significantly more efficient power grids. In addition, the way in which rivers of electric currents course through them means superconductors can serve as powerful electromagnets, for applications such as maglev trains, better MRI scanners for medicine, doubling the amount of power generated from wind turbines, and nuclear fusion power plants.

“Today, companies around the world are fabricating kilometer-long, high-temperature superconductor wires,” says Amit Goyal, SUNY Distinguished Professor and SUNY Empire Innovation Professor at the University of Buffalo in New York.

However, many large-scale applications for superconductors may stay fantasies until researchers can find a way to fabricate high-temperature superconducting wires in a more cost-effective manner.

In the new research, scientists have created wires that have set new records for the amount of current they can carry at temperatures ranging from 5 K to 77 K. Moreover, fabrication of the new wires requires processes no more complex or costly than those currently used to make high-temperature superconducting wires.

“The performance we have reported in 0.2-micron-thick wires is similar to wires almost 10 times thicker,” Goyal says.

At 4.2 K, the new wires carried 190 million amps per square centimeter without any externally applied magnetic field. This is some 50 percent better than results reported in 2022 and a full 100 percent better than ones detailed in 2021, Goyal and his colleagues note. At 20 K and under an externally applied magnetic field of 20 tesla—the kind of conditions envisioned for fusion applications—the new wires may carry about 9.3 million amps per square centimeter, roughly 5 times greater than present-day commercial high-temperature superconductor wires, they add.

Another factor key to the success of commercial high-temperature superconductor wires is pinning force—the ability to keep magnetic vortices pinned in place within the superconductors that could otherwise interfere with electron flow. (So in that sense higher pinning force values are better here—more conducive to the range of applications expected for such high-capacity, high-temperature superconductors.) The new wires showed record-setting pinning forces of more than 6.4 trillion newtons at 4.3 K under a 7 tesla magnetic field. This is more than twice as much as results previously reported in 2022.

The new wires are based on rare-earth barium copper oxide (REBCO). The wires use nanometer-sized columns of insulating, non-superconducting barium zirconate at nanometer-scale spacings within the superconductor that can help pin down magnetic vortices, allowing for higher supercurrents.

The researchers made these gains after a few years spent optimizing deposition processes, Goyal says. “We feel that high-temperature superconductor wire performance can still be significantly improved,” he adds. “We have several paths to get to better performance and will continue to explore these routes.”

Based on these results, high-temperature superconductor wire manufacturers “will hopefully further optimize their deposition conditions to improve the performance of their wires,” Goyal says. “Some companies may be able to do this in a short time.”

The hope is that superconductor companies will be able to significantly improve performance without too many changes to present-day manufacturing processes. “If high-temperature superconductor wire manufacturers can even just double the performance of commercial high-temperature superconductor wires while keeping capital equipment costs the same, it could make a transformative impact to the large-scale applications of superconductors,” Goyal says.

The scientists detailed their findings on 7 August in the journal Nature Communications.

This story was updated on 19 August 2024 to correct Amit Goyal’s title and affiliation.

Blood pressure is one of the critical vital signs for health, but standard practice can only capture a snapshot, using a pressure cuff to squeeze arteries. Continuous readings are available, but only by inserting a transducer directly into an artery via a needle and catheter. Thanks to researchers at Caltech, however, it may soon be possible to measure blood pressure continuously at just about any part of the body.

In a paper published in July in PNAS Nexus, the researchers describe their resonance sonomanometry (RSM) approach to reading blood pressure. This new technology uses ultrasound to measure the dimensions of artery walls. It also uses sound waves to find resonant frequencies that can reveal the pressure within those walls via arterial wall tension. This information is sufficient to calculate the absolute pressure within the artery at any moment, without the need for calibration.

This last factor is important, as other non-invasive approaches only provide relative changes in blood pressure. They require periodic calibration using readings from a traditional pressure cuff. The RSM technology eliminates the need for calibration, making continuous readings more reliable.

How resonance sonomanometry works

The researchers’ RSM system uses an ultrasound transducer to measure the dimensions of the artery. It also transmits sound waves at different frequencies. The vibrations cause the arterial walls to move in and out in response, creating a distinct pattern of motion. When the resonant frequency is transmitted, the top and bottom of the artery will move in and out in unison.

This resonant frequency can be used to determine the tension of the artery walls. The tension in the walls is directly correlated with the fluid pressure of the blood within the artery. As a result, the blood pressure can be calculated at any instant based on the dimensions of the artery and its resonant frequency.

The researchers have validated this approach with both mockups and human subjects. They first tested the technology on an arterial model that used a thin-walled rubber tubing and a syringe to vary the pressure. They tested this mockup using multiple pressures and tubing of different diameters.

The researchers then took measurements with human subjects at their carotid arteries (located in the neck), using a standard pressure cuff to take intermittent measurements. The RSM technology was successful, and subsequently was also demonstrated on axillary (shoulder), brachial (arm), and femoral (leg) arteries. The readings were so clear that the researchers mention that they might even be able to detect blood pressure changes related to respiration and its impact on thoracic pressure.

Unlike traditional pressure cuff approaches, RSM provides data during the entire heartbeat cycle, and not just the systolic and diastolic extremes (In other words, the two numbers you receive during a traditional blood pressure measurement). And the fact that RSM works with different-sized arteries means that it should be applicable across different body sizes and types. Using ultrasound also eliminates possible complications such as skin coloration that can affect light-based devices.

The researchers tested their ultrasound-based blood pressure approach on subjects’ carotid arteries.Esperto Medical

“I’m a big fan of continuous monitoring; a yearly blood pressure reading in the doctor’s office is insufficient for decision making,” says Nick van Terheyden, M.D., the digital health leader with Iodine Software, a company providing machine learning technologies to improve healthcare insights. “A new approach based on good old rules of math and physics is an exciting development.”

The Caltech researchers have created a spinoff company, Esperto Medical, to develop a commercial product using RSM technology. The company has created a transducer module that is smaller than a deck of cards, making it practical to incorporate into a wearable armband. They hope to miniaturize the hardware to the point that it could be incorporated into a wrist-worn device. According to Raymond Jimenez, Esperto Medical’s chief technology officer, “this technology poses the potential to unlock accurate, calibration-free [blood pressure measurements] everywhere—in the clinic, at the gym, and even at home.”

It appears that there’s a significant market for such a product. “92 percent of consumers who intend to buy a wearable device are willing to pay extra for a health-related feature, and blood pressure ranks first among such features,” says Elizabeth Parks, the president of Internet of Things consulting firm Parks Associates.

In the future, rather than relying on arm-squeezing blood pressure cuffs, smart watches may be able to directly monitor blood pressure throughout the day, just as they already do for heart rate and other vital signs.

The teachings of Mahatma Gandhi were arguably India’s greatest contribution to the 20th century. Raghunath Anant Mashelkar has borrowed some of that wisdom to devise a frugal new form of innovation he calls “Gandhian engineering.” Coming from humble beginnings, Mashelkar is driven to ensure that the benefits of science and technology are shared more equally. He sums up his philosophy with the epigram “more from less for more.” This engineer has led India’s preeminent R&D organization, the Council of Scientific and Industrial Research, and he has advised successive governments.

What was the inspiration for Gandhian engineering?

Raghunath Anant Mashelkar: There are two quotes of Gandhi’s that were influential. The first was, “The world has enough for everyone’s need, but not enough for everyone’s greed.” He was saying that when resources are exhaustible, you should get more from less. He also said the benefits of science must reach all, even the poor. If you put them together, it becomes “more from less for more.”

My own life experience inspired me, too. I was born to a very poor family, and my father died when I was six. My mother was illiterate and brought me to Mumbai in search of a job. Two meals a day was a challenge, and I walked barefoot until I was 12 and studied under streetlights. So it also came from my personal experience of suffering because of a lack of resources.

How does Gandhian engineering differ from existing models of innovation?

Mashelkar: Conventional engineering is market or curiosity driven, but Gandhian engineering is application and impact driven. We look at the end user and what we want to achieve for the betterment of humanity.

Most engineering is about getting more from more. Take an iPhone: They keep creating better models and charging higher prices. For the poor it is less from less: Conventional engineering looks at removing features as the only way to reduce costs.

In Gandhian engineering, the idea is not to create affordable [second-rate] products, but to make high technology work for the poor. So we reinvent the product from the ground up. While the standard approach aims for premium price and high margins, Gandhian engineering will always look at affordable price, but high volumes.

The Jaipur foot is a light, durable, and affordable prosthetic.Gurinder Osan/AP

What is your favorite example of Gandhian engineering?

Mashelkar: My favorite is the Jaipur foot. Normally, a sophisticated prosthetic foot costs a few thousand dollars, but the Jaipur foot does it for [US] $20. And it’s very good technology; there is a video of a person wearing a Jaipur foot climbing a tree, and you can see the flexibility is like a normal foot. Then he runs one kilometer in 4 minutes, 30 seconds.

What is required for Gandhian engineering to become more widespread?

Mashelkar: In our young people, we see innovation and we see passion, but compassion is the key. We also need more soft funding [grants or zero-interest loans], because venture capital companies often turn out to be “vulture capital” in a way, because they want immediate returns.

We need a shift in the mindset of businesses—they can make money not just from premium products for those at the top of the pyramid, but also products with affordable excellence designed for large numbers of people.

This article appears in the November 2024 print issue as “The Gandhi Inspired Inventor.”

AbbVie schizophrenia drug candidate emraclidine failed to beat a placebo in two Phase 2 clinical trials. The drug, once projected to compete with Bristol Myers Squibb’s Cobenfy, is from AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics.

The post AbbVie Drug Expected to Rival Bristol Myers’s New Schizophrenia Med Flunks Phase 2 Test appeared first on MedCity News.

Faulty diagnostic tests can compromise both patient care and the nation’s response to infectious diseases—as made all too clear earlier this month when the Food and Drug Administration issued a safety alert about a COVID-19 test that carries a high risk of false negative results.

Dr. Cassandra Quave’s path to her work as a leader in antibiotic drug discovery research initiatives at Emory University in Atlanta started when she was a child and she and her family dealt with her own serious health issues that have had life-long repercussions.

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading

Day 3 of the JPMorgan healthcare conference was one of striking contrasts between the old and the new. (And, by the way, the rain finally stopped for a day, but it will be back tomorrow to finish off the last day of the conference). The Old:  Sitting in the Community Health Systems (CHS) presentation and...… Continue Reading

This paper highlights the many enhancements to SAS/ETS software and demonstrates how these features can help your organization increase revenue and enhance productivity.

This paper provides a high-level tour of five modern approaches to model building that are available in recent releases of SAS/STAT.

My Chemical Romance teased a new project on social media. The Welcome to the Black Parade rockers — who broke up in 2013 before releasing new song The Foundations of Decay nine years later — have largely kept things quiet since their reunion tour ended in March 2023, besides a headline slot at When We Were Young Festival last month. On Monday (Nov 11), the band's official Instagram shared an image of a hazy skyline and confetti alongside Russian letters which translate to "TPK". The cryptic post was captioned: "If you could be anything, what would you be?" https://www.instagram.com/p/DCPw84izQkN/?utm_source=ig_web_copy_link&igsh=MzRlODBiNWFlZA== While there are no further hints about the message and what it could mean, fans have suggested it may refer to MCR's scrapped record The Paper Kingdom, which was ditched in 2013 and would have been their fifth album.

WASHINGTON — US President-elect Donald Trump said on Nov 12 that Elon Musk and former Republican presidential hopeful Vivek Ramaswamy will lead the newly created Department of Government Efficiency. Musk and Ramaswamy "will pave the way for my Administration to dismantle Government Bureaucracy, slash excess regulations, cut wasteful expenditures, and restructure Federal Agencies", Trump said in a statement. Trump said their work would conclude by July 4, 2026, adding that a smaller and more efficient government would be a "gift" to the country on the 250th anniversary of the signing of the Declaration of Independence. Businessman and former Republican presidential candidate Vivek Ramaswamy attends Donald Trump's campaign event sponsored by conservative group Turning Point Action, in Las Vegas, Nevada, US, Oct 24, 2024. PHOTO: Reuters file The appointments reward two Trump supporters from the private sector.

Dec 5, 2023

David W. Kearn argues that deployment of nuclear weapons cannot rectify a perceived imbalance in conventional forces in the western Pacific.