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Case Study: When does “technology” turn into medical device

This semester I’ve embarked on an adventure to co-teach a class in the University of Wisconsin-Madison Masters in Biotechnology program. What sold me on the experience was the majority of my responsibility is interacting with second year students on their final major project (essentially their thesis). That said, I will give one lecture, which will be “health

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New EU Rules for Medical Devices

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




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New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]





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Yokogawa Releases SensPlus Note, an OpreX Operation and Maintenance Improvement Solution for the Digitization of Field Data Using Mobile Devices

Yokogawa Electric Corporation (TOKYO: 6841) and MetaMoJi Corporation announce that they have jointly developed SensPlus Note, a low cost and easy to implement solution for the digitization of plant data on mobile devices. SensPlus Note, a solution in Yokogawa's OpreX Operation and Maintenance Improvement family, improves the efficiency and quality of maintenance work and the precision of post-maintenance analyses by enabling data from plant field work to be used more efficiently. This solution will be released in all markets worldwide on January 31.




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Browser testing across devices with Adobe Edge Inspect

Discover how to test your websites and web apps in the browser across desktops and mobile devices using Adobe Edge Inspect.




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The medical device tax: A primer


Quickly following on the heels of the midterm elections, Senate Majority Leader Mitch McConnell (R-KY) indicated that the medical device tax was a key target for repeal in the 114th Congress. Today, the Senate Finance Health Care Subcommittee will hold a hearing about the effects of the 2.3 percent tax that was included in the Affordable Care Act. Many believe that a repeal is, in fact, possible. Below is a basic primer about the tax and its contentious history.

1. What is the medical device tax?

Included in the Affordable Care Act (ACA) and launched in 2013, the medical device tax imposes a 2.3 percent sales tax on medical device supplies. The tax applies broadly to a range of products, including pacemakers, artificial joints, surgical gloves, and dental instruments. It does not apply to eyeglasses, contact lenses, hearing aids, wheelchairs, or any other device that the public generally buys for individual use. Further, the tax is applied equally to imported and domestically produced devices, and devices produced in the U.S. for export are tax-exempt.

2. Why was it included in the Affordable Care Act?

According to the Joint Committee on Taxation, the tax is estimated to bring in $29 billion over the next decade. The tax was one of many revenue-raising provisions designed to offset the cost of providing coverage to more than 25 million Americans through the ACA, and these newly insured individuals would likewise increase demand for medical device manufacturers' products and services. Other industries were subject to levies as well, including health plans (an estimated $101 billion), and employers (an estimated $130 billion). It has been noted that then-Senator John Kerry from Massachusetts helped negotiate the tax from 4.6 percent to 2.3 percent.

3. How has the medical device industry responded?

The U.S. is home to more than 7,000 medical device companies with estimated annual sales of $106 to $116 billion per year. The largest concentrations of companies are located in California, Massachusetts, New York and Minnesota. Since 2010, the medical device industry has led a full court press effort to repeal the tax. Companies and trade groups argue that the tax would cost over 40,000 U.S. jobs, and undermine innovation by moving manufacturing offshore - conclusions that are heavily contested by the tax's supporters.

By some accounts this tax is coming at a particularly challenging time for medical device innovation. A recent analysis by Ernst & Young reported that venture capital investment in medical devices in 2013 fell 17% from the previous year, a downward trend that has been observed for the past seven years. In addition, investment funding is also shifting towards less risky later-stage medical device companies instead of smaller earlier stage ventures. These trends are worrisome since early-stage investment companies can promote innovative and disruptive medical device technologies that introduce new therapeutic benefits or quantum improvements in patient care.

It is unclear what impact the medical device tax will have on investment in early stage innovation. Key factors that have reduced the availability of venture capital for early-stage medical device companies pursuing pre-market approval include U.S. regulatory unpredictability and delays in approval, and an uncertain reimbursement environment. Additionally, efforts outside the U.S to attract medical device investment, such as offering tax havens and other incentives for device developers in Ireland and the Netherlands add to the attractiveness for device companies to move out of the U.S. Moving to a country that has lower tax rates and less stringent corporate governance requirements may save large device companies billions of dollars.

Recognizing that the "country of first choice by medical device developers is a key contributor to early patient access to high-quality, safe and effective devices," the Center for Devices and Radiological Health's (CDRH) at the U.S. Food and Drug Administration issued its 2014-2015 Strategic Priorities, which describe their efforts to improve regulatory predictability and device development efficiency in order to "help medical device developers choose the U.S. as the country of first choice for their technologies." While the FDA's efforts seem to focus on encouraging medical device innovation in the U.S., the medical device tax seems to be contradictory to this effort.

Some also argue that while expanding insurance coverage will help drug companies sell more products and bring in new patients for providers and hospitals, it will not help sell more devices because the majority of potential beneficiaries are much older and already covered by Medicare.

Hundreds of companies and trade groups have signed on to letters opposing the tax from industry associations, like the Medical Device Manufacturers Association (MDMA) and AdvaMed. Others have launched significant lobbying efforts to support the tax's repeal, an industry that accounts for $30 million in lobbying expenditures annually since the ACA was passed in 2010. The Center for Responsible Politics has also identified $5.7 million in political contributions on behalf of medical device companies to specific candidates during the 2013-2014 campaign cycle.

4. How are lawmakers responding?

The tax's repeal has been supported by Democrats and Republicans alike. Many opponents cite the Senate's fiscal 2014 budget resolution as an indicator of support - drumming up 79 supporters for repeal, including 33 Democrats. However, the resolution "was non-binding and viewed as a free vote to show displeasure with an unpopular aspect of the health law." The tax's repeal has garnered outspoken support from Orrin Hatch (R-UT) and Mitch McConnell (R-KY), as well as Elizabeth Warren (D-MA), Al Franken (D-MN), Amy Klobuchar (D-MN) - Democrats with notably high concentrations of medical device companies in their states. The House has approved the repeal of the device tax three separate times in the past two years, including as recently as September 2014. The White House has historically opposed these efforts, but President Obama recently indicated he would entertain the idea.

A report from the nonpartisan Congressional Research Service, released last week, concluded that the tax is unlikely to hurt the profits of device companies, estimating that it will reduce industry output and employment by no more than .2 percent. CRS states, "The effect on the price of health care, however, will most likely be negligible because of the small size of the tax and small share of health care spending attributable to medical devices." A separate report from Ernst & Young last month finds that domestic revenues for medical technology firms grew 4 percent to $336 billion in 2013, the first year the tax went into effect - about the same rate from 2012, indicating that the industry seems financially stable for now.

Editor’s note: This post was originally featured in RealClear Markets on November 12, 2014. Click here for the original posting.

      




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Why legislative proposals to improve drug and device development must look beyond FDA approvals


Legislative proposals to accelerate and improve the development of innovative drugs and medical devices generally focus on reforming the clinical development and regulatory review processes that occur before a product gets to market. Many of these proposals – such as boosting federal funding for basic science, streamlining the clinical trials process, improving incentives for development in areas of unmet medical need, or creating expedited FDA review pathways for promising treatments – are worthy pursuits and justifiably part of ongoing efforts to strengthen biomedical innovation in the United States, such as the 21st Century Cures initiative in the House and a parallel effort taking shape in the Senate.

What has largely been missing from these recent policy discussions, however, is an equal and concerted focus on the role that postmarket evidence can play in creating a more robust and efficient innovation process. Data on medical product safety, efficacy, and associated patient outcomes accrued through routine medical practice and through practical research involving a broad range of medical practices could not only bolster our understanding of how well novel treatments are achieving their intended effects, but reinforce many of the premarket reforms currently under consideration. Below and in a new paper, we highlight the importance of postmarket evidence development and present a number of immediately achievable proposals that could help lay the foundation for future cures.

Why is postmarket evidence development important?

There are a number of reasons why evidence developed after a medical product’s approval should be considered an integral part of legislative efforts to improve biomedical innovation. First and foremost, learning from clinical experiences with medical products in large patient populations can allow providers to better target and treat individuals, matching the right drug or device to the right patient based on real-world evidence. Such knowledge can in turn support changes in care that lead to better outcomes and thus higher value realized by any given medical product.

Similarly, data developed on outcomes, disease progression, and associated genetic and other characteristics that suggest differences in disease course or response to treatment can form the foundation of future breakthrough medical products. As we continue to move toward an era of increasingly-targeted treatments, this important of this type of real-world data cannot be discounted.

Finally, organized efforts to improve postmarket evidence development can further establish infrastructure and robust data sources for ensuring the safety and effectiveness of FDA-approved products, protecting patient lives. This is especially important as Congress, the Administration, and others continue to seek novel policies for further expediting the pre-market regulatory review process for high-priority treatments. Without a reliable postmarket evidence development infrastructure in place, attempts to further shorten the time it takes to move a product from clinical development to FDA approval may run up against the barrier of limited capabilities to gather the postmarket data needed to refine a product’s safety and effectiveness profile. While this is particularly important for medical devices – the “life cycle” of a medical device often involves many important revisions in the device itself and in how and by whom it is used after approval – it is also important for breakthrough drugs, which may increasingly be approved based on biomarkers that predict clinical response and in particular subpopulations of patients.

What can be done now?

The last decade has seen progress in the availability of postmarket data and the production of postmarket evidence. Biomedical researchers, product developers, health care plans, and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the powerful effects that rigorous, systematic postmarket data collection can have on our understanding of how medical products perform in the real-world and of the course of underlying diseases that they are designed to treat.

These and other postmarket data systems now hold the potential to contribute to data analysis and improved population-based evidence development on a wider scale. Federal support for strengthening the processes and tools through which data on important health outcomes can be leveraged to improve evidence on the safety, effectiveness, and value of care; for creating transparent and timely access to such data; and for building on current evidence development activities will help to make the use of postmarket data more robust, routine, and reliable.

Toward that end, we put forward a number of targeted proposals that current legislative efforts should consider as the 2015 policy agenda continues to take shape:

Evaluate the potential use of postmarket evidence in regulatory decision-making. The initial Cures discussion draft mandated FDA to establish a process by which pharmaceutical manufacturers could submit real-world evidence to support Agency regulatory decisions. While this is an important part of further establishing methods and mechanisms for harnessing data developed in the postmarket space, the proposed timelines (roughly 12 months to first Guidance for Industry) and wide scope of the program do not allow for a thoughtfully-, collaboratively-considered approach to utilizing real-world evidence. Future proposals should allow FDA to take a longer, multi-stakeholder approach to identify the current sources of real-world data, gaps in such collection activities, standards and methodologies for collection, and priority areas where more work is needed to understand how real-world data could be used.

Expand the Sentinel System’s data collection activities to include data on effectiveness. Established by Congress in 2007, Sentinel is a robust surveillance system geared toward monitoring the safety of drugs and biologics. In parallel to the program for evaluating the use of RWE outlined above, FDA could work with stakeholders to identify and pursue targeted extensions of the Sentinel system that begin to pilot collection of such data. Demonstration projects could enable faster and more effective RWE development to characterize treatment utilization patterns, further refine a product’s efficacy profile, or address pressing public health concerns – all by testing strategic linkages to data elements outside of Sentinel’s safety focus.

Establish an active postmarket safety surveillance system for medical devices. Congress has already acted once to establish device surveillance, mandating in 2012 that Sentinel be expanded to include safety data on medical devices. To date, however, there has been no additional support for such surveillance or even the capability of individually tracking medical devices in-use. With the recently finalized Unique Device Identifier rule going effect and the ability to perform such tracking on the horizon, the time is now to adopt recent proposals from FDA’s National Medical Device Postmarket Surveillance System Planning Board. With Congressional authorization for FDA to establish an implementation plan and adequate appropriations, the true foundation for such a system could finally be put into place.

These next steps are practical, immediately achievable, and key to fully realizing the intended effect of other policy efforts aimed at both improving the biomedical innovation process and strengthening the move to value-based health care.

Authors

      




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New Wave Energy Device Could See 200 Commercial Units in the Next Five Years

The Searaser takes a novel approach to wave energy generation. New owners Ecotricity - pioneers of wind power in Britain - are aiming for mass deployment in the next five years.




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Concept for smarter wave power device a winner in GE's Ecomagination Challenge

The company says this system is simpler than other wave devices that need to be finely tuned to the waves to pick up their energy.




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Simple device turns your ordinary home into a smart home

The device monitors the energy use of all the power loads in your house.




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When smart devices jump the shark: An 'intelligent device' for your garbage can

And now, in the 'Give me a break' category, the folks behind this garbage can scanner assume you can't make a grocery list on your own.




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Life with a Sense home energy monitor: More devices, real savings

I knew that real-time data on our energy use would be interesting. But I wasn't sure how much it would actually save us.




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New York State lawmakers want to ban walking with portable electronic devices

There are all kinds of distracted and compromised people in our roads. Some of them cannot help it. So why are phones a problem?




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Mini-sized hydropower plant charges your devices on the go

For backpackers wanting something other than solar power.




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Skin patch could power personal devices

The shiny sticker generates energy from movement.




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Flexible device harvests body heat to power wearable electronics

The material can also heal itself to keep medical devices running indefinitely.




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Device that harvests energy from human motion could be seamlessly integrated into clothing

The device is so thin it could be woven into fabric without changing the feel of it.




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Mobile solar-plus-storage device could be an entry-level gateway to clean energy

The SolPad Mobile device offers a scaled-up solar charging and battery solution for both home and off-grid applications.




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Jenni is a gateway device for small-scale solar for apartment & condo dwellers

The Jenni solar charger and battery pack aims to make it easy to begin going solar at home, starting with your portable electronics




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Small loads from Internet-connected devices all add up

Our always-on devices turn out to consume a lot of power. Do I really need to connect my garage door to the Internet?




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SodaStream launches device to clean plastics from ocean

This is the first-known attempt of a commercial company to undertake a physical clean-up of trash from open waters.




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Become a bat detective with this plug-in device for your smartphone

The Echo Meter can detect, record and identify the sounds of bats nearby.




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Public charging station powers mobile devices with footsteps and solar panels

The ENGO charging station uses kinetic tiles and solar panels to charge up to 14 smartphones at a time, and provides free WiFi access and an emergency phone.




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61% of Mobile Workers Trust Their Employer to Keep Personal Information Private on Their Mobile Devices - What can employers see on smartphones

Smartphones hold increasing amounts of sensitive personal data, so every device is now a mixed-use device. As a result, businesses must protect employee privacy as fiercely as corporate security.




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Eyeglass World Launches First Retail Collection of Prescription Lenses for Smart Glass Devices - Future of Eyewear

Eyeglass World launches first retail collection of smart glass technologies in the U.S., including specially designed prescription lens options and hardware for Recon, Vuzix and Epson wearable devices.




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Trader says 'no guidance, no problem' for this medical device company—Here's why

Is Abbott Labs a buy? With CNBC's Melissa Lee and the Fast Money traders, Guy Adami, Tim Seymour, Pete Najarian and Steve Grasso.




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Complex Devices




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The US Navy patented a device to make laser ‘ghost planes’ in mid-air

The US Navy is researching how to use lasers to form plasma into 2D or 3D infrared images of aeroplanes that can distract heat-seeking missiles




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Pocket-sized device tests DNA in blood samples for genetic conditions

A cheap, lightweight smartphone-heated device can test for DNA in blood, urine and other samples in a fraction of the time it takes to test in a lab




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Electrical devices implanted in the brain may help treat anorexia

In a small trial, implanting electrodes into the brain helped women with severe anorexia gain weight and feel less anxious and depressed




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Plug-in Interface Will Soon Usher in New Generation of Compact Medical Devices

UC Davis researchers have designed a plug-in interface which will usher in the new generation of compact medical devices. "We think there is a huge




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New Miniature Dental Device Leads to a More Personalized Dentistry

The new 'tooth-on-a-chip' was found to enable more personalized dentistry, giving dentists the ability to identify dental filling materials that work




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Devices Helping in Training and Treating Injuries in Runners Discovered

As wearable fitness trackers become ever more popular and sophisticated, they provide new opportunities for monitoring training and guiding post-injury




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New Device can Help High-quality Blood Donors

New device developed at UBC is showing promise as a method to recognize "super donors," potentially aiding over 4.5 million patients who need blood transfusions




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Affordable Insulin Option Can Now Be Used By Patients With Type 2 Diabetes Through Wearable Device

Using regular human insulin (RHI) in a wearable, patch-like insulin delivery device with type 2 diabetes helps adults requiring insulin therapy safely achieve good blood sugar control.




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Next-Generation Lab Nanodevice can Help Detect Bacteria and Viruses

New process improves lab-on-chip devices to separate drug-resistant strains of bacterial infection, viruses. The findings of the study are published in




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Is Content Regulation Really Necessary For Kids On Devices?

Parents have been found to monitor only the mobile usage time and not what the kids actually see in these devices. The Content also needs to regulated,




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Sniffing Out Microphones and Other Bugging Devices Yourself




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Switzerland Imports of Measure Examine & Control Devices

Imports of Measure, Examine & Control Devices in Switzerland increased to 319.28 CHF Million in March from 291.73 CHF Million in February of 2020. Imports of Measure, Examine & Control Devices in Switzerland averaged 278.77 CHF Million from 2014 until 2020, reaching an all time high of 339.35 CHF Million in October of 2019 and a record low of 210.88 CHF Million in January of 2016. This page includes a chart with historical data for Switzerland Imports of Measure, Examine & Control Devices.




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Switzerland Imports - Machines & Devices To The Service Industries

Imports - Machines & Devices To The Service Industries in Switzerland increased to 1069.53 CHF Million in March from 902.37 CHF Million in February of 2020. Imports - Machines & Devices To The Service Indust in Switzerland averaged 1073.81 CHF Million from 2014 until 2020, reaching an all time high of 1395.77 CHF Million in November of 2017 and a record low of 856.27 CHF Million in August of 2015. This page includes a chart with historical data for Switzerland Imports of Machines & Devices to The Service Indu.




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Switzerland Imports - Machines & Devices To The Equip. Of Bldg.

Imports - Machines & Devices To The Equip. Of Bldg. in Switzerland increased to 195.08 CHF Million in March from 183.92 CHF Million in February of 2020. Imports - Machines & Devices To The Equip. Of Bldg in Switzerland averaged 185.61 CHF Million from 2014 until 2020, reaching an all time high of 234.78 CHF Million in July of 2019 and a record low of 138.88 CHF Million in January of 2015. This page includes a chart with historical data for Switzerland Imports of Machines & Devices to The Equip. of Bl.




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Switzerland Imports of Machines & Devices

Imports of Machines & Devices in Switzerland increased to 959.16 CHF Million in March from 879.28 CHF Million in February of 2020. Imports of Machines & Devices in Switzerland averaged 875.21 CHF Million from 2014 until 2020, reaching an all time high of 1022.39 CHF Million in July of 2019 and a record low of 684.19 CHF Million in January of 2016. This page includes a chart with historical data for Switzerland Imports of Machines & Devices.




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Switzerland Imports of Game Sport & Leisure Devices

Imports of Game, Sport & Leisure Devices in Switzerland decreased to 104.63 CHF Million in March from 105.43 CHF Million in February of 2020. Imports of Game, Sport & Leisure Devices in Switzerland averaged 118.29 CHF Million from 2014 until 2020, reaching an all time high of 160.43 CHF Million in September of 2019 and a record low of 79.82 CHF Million in May of 2015. This page includes a chart with historical data for Switzerland Imports of Game, Sport & Leisure Devices.




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Mass securitisation as a device for recovery has no economic value

Tweaking pre-pandemic indirect EU subsidies is not the way to rescue struggling businesses




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5G devices were less than 1% of US smartphone purchases in 2019

No surprise, really, that 5G smartphone sales are on the way up. Frankly, there’s really no other way to go, according to the latest numbers from NPD’s Mobile Phone Tracking. The firm noted that 5G handsets accounted for less than 1% of total sales in the U.S. The hurdles are also what you’d expect: namely, […]




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TiVo enters the streaming market with a $50 Android TV-powered device, TiVo Stream 4K

TiVo today is launching a new device, its would-be Fire TV Stick competitor known as the TiVo Stream 4K. First announced at the Consumer Electronics Show in January, this $50 Android TV-powered HDMI dongle is TiVo’s attempt to insert itself into the streaming media device market. The new dongle arrives at a time when TiVo […]




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Apple Watch designer reveals the device’s origins on its fifth birthday

Update: We mistakenly noted in an earlier version that Chaudhri had been a part of Microsoft’s Hololens team. The story has been updated to remove the reference.  In his two decades at Apple, Imran Chaudhri worked on many of the company’s most iconic product lines, including the iPhone, iPad and Mac. The designer left the […]




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FDA authorizes production of a new ventilator that costs up to 25x less than existing devices

The U.S. Food and Drug Administration (FDA) has authorized the manufacture of the Coventor ventilator, a new hardware design first developed by the University of Minnesota. The project sought to create a ventilator that could provide the same level of life-saving care as existing ventilator models, but with a much lower cost to help ramp […]




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Apple Watch designer reveals the device’s origins on its fifth birthday

Update: We mistakenly noted in an earlier version that Chaudhri had been a part of Microsoft’s Hololens team. The story has been updated to remove the reference.  In his two decades at Apple, Imran Chaudhri worked on many of the company’s most iconic product lines, including the iPhone, iPad and Mac. The designer left the […]