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Waiver of Informed Consent - proposed changes in the 21st Century Cures Act

Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21st Century Cures Act:


In another tweet, he suggests that the act will "decimate" informed consent in drug trials. Subsequent responses and retweets  did nothing to clarify the situation, and if anything tended to spread, rather than address, Feuerstein's confusion.

Below is a quick recap of the current regulatory context and a real-life example of where the new wording may be helpful. In short, though, I think it's safe to say:


  1. Waiving informed consent is not new; it's already permitted under current regs
  2. The standards for obtaining a waiver of consent are stringent
  3. They may, in fact, be too stringent in a small number of situations
  4. The act may, in fact, be helpful in those situations
  5. Feuerstein may, in fact, need to chill out a little bit


(For the purposes of this discussion, I’m talking about drug trials, but I believe the device trial situation is parallel.)

Section 505(i) - the section this act proposes to amend - instructs the Secretary of Health and Human Services to propagate rules regarding clinical research. Subsection 4 addresses informed consent:

…the manufacturer, or the sponsor of the investigation, require[e] that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where it is not feasible or it is contrary to the best interests of such human beings.

[emphasis  mine]

Note that this section already recognizes situations where informed consent may be waived for practical or ethical reasons.

These rules were in fact promulgated under 45 CFR part 46, section 116. The relevant bit – as far as this conversation goes – regards circumstances under which informed consent might be fully or partially waived. Specifically, there are 4 criteria, all of which need to be met:

 (1) The research involves no more than minimal risk to the subjects;
 (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
 (3) The research could not practicably be carried out without the waiver or alteration; and
 (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

In practice, this is an especially difficult set of criteria to meet for most studies. Criterion (1) rules out most “conventional” clinical trials, because the hallmarks of those trials (use of an investigational medicine, randomization of treatment, blinding of treatment allocation) are all deemed to be more than “minimal risk”. That leaves observational studies – but even many of these cannot clear the bar of criterion (3).

That word “practicably” is a doozy.

Here’s an all-too-real example from recent personal experience. A drug manufacturer wants to understand physicians’ rationales for performing a certain procedure. It seems – but there is little hard data – that a lot of physicians do not strictly follow guidelines on when to perform the procedure. So we devise a study: whenever the procedure is performed, we ask the physician to complete a quick form categorizing why they made their decision. We also ask him or her to transcribe a few pieces of data from the patient chart.

Even though the patients aren’t personally identifiable, the collection of medical data qualifies this as a clinical trial.

It’s a minimal risk trial, definitely: the trial doesn’t dictate at all what the doctor should do, it just asks him or her to record what they did and why, and supply a bit of medical context for the decision. All told, we estimated 15 minutes of physician time to complete the form.

The IRB monitoring the trial, however, denied our request for a waiver of informed consent, since it was “practicable” (not easy, but possible) to obtain informed consent from the patient.  Informed consent – even with a slimmed-down form – was going to take a minimum of 30 minutes, so the length of the physician’s involvement tripled. In addition, many physicians opted out of the trial because they felt that the informed consent process added unnecessary anxiety and alarm for their patients, and provided no corresponding benefit.

The end result was not surprising: the budget for the trial more than doubled, and enrollment was far below expectations.

Which leads to two questions:

1.       Did the informed consent appreciably help a single patient in the trial? Very arguably, no. Consenting to being “in” the trial made zero difference in the patients’ care, added time to their stay in the clinic, and possibly added to their anxiety.
2.       Was less knowledge collected as a result? Absolutely, yes. The sponsor could have run two studies for the same cost. Instead, they ultimately reduced the power of the trial in order to cut losses.


Bottom line, it appears that the modifications proposed in the 21st Century Cures Act really only targets trials like the one in the example. The language clearly retains criteria 1 and 2 of the current HHS regs, which are the most important from a patient safety perspective, but cuts down the “practicability” requirement, potentially permitting high quality studies to be run with less time and cost.

Ultimately, it looks like a very small, but positive, change to the current rules.

The rest of the act appears to be a mash-up of some very good and some very bad (or at least not fully thought out) ideas. However, this clause should not be cause for alarm.




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Hospitals face months of IV fluid shortages after Helene damages N.C. factory

Hospitals have been forced to innovate with new ways of hydrating patients and giving them medications, after a key factory that produces IV fluid bags flooded during Hurricane Helene. (This story first aired on Morning Edition on Nov. 7, 2024.)




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Patrick Dempsey aims to raise awareness of cancer disparities and encourage screening

NPR's Leila Fadel talks with actor Patrick Dempsey about his efforts to raise money for cancer treatment and prevention.




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Remarkably resilient refugees: A teen on his own, a woman who was raped

Sudan's civil war has displaced 10 million citizens. Here are profiles of two young people from the most vulnerable groups: an unaccompanied minor caring for twin brothers, a woman who was raped.




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“Snake-like” Probe Images Arteries from Within



Neurosurgeon Vitor Mendes Pereira has grown accustomed to treating brain aneurysms with only blurry images for guidance.

Equipped with a rough picture of the labyrinthine network of arteries in the brain, he does his best to insert mesh stents or coils of platinum wire—interventions intended to promote clotting and to seal off a bulging blood vessel.

The results are not always perfect. Without a precise window into the arterial architecture at the aneurysm site, Pereira says that he and other neurovascular specialists occasionally misplace these implants, leaving patients at a heightened risk of stroke, clotting, inflammation, and life-threatening ruptures. But a new fiber-optic imaging probe offers hope for improved outcomes.

Pereira et al./Science Translational Medicine

According to Pereira’s early clinical experience, the technology—a tiny snake-like device that winds its way through the intricate maze of brain arteries and, using spirals of light, captures high-resolution images from the inside-out—provides an unprecedented level of structural detail that enhances the ability of clinicians to troubleshoot implant placement and better manage disease complications.

“We can see a lot more information that was not accessible before,” says Pereira, director of endovascular research and innovation at St. Michael’s Hospital in Toronto. “This is, for us, an incredible step forward.”

And not just for brain aneurysms. In a report published today in Science Translational Medicine, Pereira and his colleagues describe their first-in-human experience using the platform to guide treatment for 32 people with strokes, artery hardening, and various other conditions arising from aberrant blood vessels in the brain.

Whereas before, with technologies such as CT scans, MRIs, ultrasounds, and x-rays, clinicians had a satellite-like view of the brain’s vascular network, now they have a Google Street View-like perspective, complete with in-depth views of artery walls, plaques, immune cell aggregates, implanted device positions, and more.

“The amount of detail you could get you would never ever see with any other imaging modality,” says Adnan Siddiqui, a neurosurgeon at the University at Buffalo, who was not involved in the research. “This technology holds promise to be able to really transform the way we evaluate success or failure of our procedures, as well as to diagnose complications before they occur.”

A Decade of Innovation

The new fiber-optic probe is flexible enough to snake through the body’s arteries and provide previously unavailable information to surgeons.Pereira et al./Science Translational Medicine

The new imaging platform is the brainchild of Giovanni Ughi, a biomedical engineer at the University of Massachusetts’ Chan Medical School in Worcester. About a decade ago, he set out to adapt a technique called optical coherence tomography (OCT) for imaging inside the brain’s arteries.

OCT relies on the backscattering of near-infrared light to create cross-sectional images with micrometer-scale spatial resolution. Although OCT had long been used in clinical settings to generate pictures from the back of the eye and from inside the arteries that supply blood to the heart, the technology had proven difficult to adapt for brain applications owing to several technical challenges.

One major challenge is that the fiber-optic probes used in the technology are typically quite stiff, making them too rigid to twist and bend through the convoluted passageways of the brain’s vasculature. Additionally, the torque cables—traditionally used to rotate the OCT lens to image surrounding vessels and devices in three dimensions as the probe retracts—were too large to fit inside the catheters that are telescopically advanced into the brain’s arteries to address blockages or other vascular issues.

“We had to invent a new technology,” Ughi explains. “Our probe had to be very, very flexible, but also very, very small to be compatible with the clinical workflow.”

To achieve these design criteria, Ughi and his colleagues altered the properties of the glass at the heart of their fiber-optic cables, devised a new system of rotational control that does away with torque cables, miniaturized the imaging lens, and made a number of other engineering innovations.

The end result: a slender probe, about the size of a fine wire, that spins 250 times per second, snapping images as it glides back through the blood vessel. Researchers flush out blood cells with a tablespoon of liquid, then manually or automatically retract the probe, revealing a section of the artery about the length of a lip balm tube.

St. Michael’s Foundation

Clinical Confirmation

After initial testing in rabbits, dogs, pigs, and human cadavers, Ughi’s team sent the device to two clinical groups: Pereira’s in Toronto and Pedro Lylyk’s at the Sagrada Familia Clinic in Buenos Aires, Argentina. Across the two groups, neurosurgeons treated the 32 participants in the latest study, snaking the imaging probe through the patients’ groins or wrists and into their brains.

The procedure was safe and well-tolerated across different anatomies, underlying disease conditions, and the complexity of prior interventions. Moreover, the information provided frequently led to actionable insights—in one case, prompting clinicians to prescribe anti-platelet drugs when hidden clots were discovered; in another, aiding in the proper placement of stents that were not flush against the arterial wall.

“We were successful in every single case,” Ughi says. “So, this was a huge confirmation that the technology is ready to move forward.”

“We can see a lot more information that was not accessible before.” —Vitor Mendes Pereira, St. Michael’s Hospital

A startup called Spryte Medical aims to do just that. According to founder and CEO David Kolstad, the company is in discussions with regulatory authorities in Europe, Japan, and the United States to determine the steps necessary to bring the imaging probe to market.

At the same time, Spryte—with Ughi as senior director of advanced development and software engineering—is working on machine learning software to automate the image analysis process, thus simplifying diagnostics and treatment planning for clinicians.

Bolstered by the latest data, cerebrovascular specialists like Siddiqui now say they are chomping at the bit to get their hands on the imaging probe once it clears regulatory approval.

“I’m really impressed,” Siddiqui says. “This is a tool that many of us who do these procedures wish they had.”




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Noninvasive Spinal Stimulation Gets a (Current) Boost



In 2010, Melanie Reid fell off a horse and was paralyzed below the shoulders.

“You think, ‘I am where I am; nothing’s going to change,’ ” she said, but many years after her accident, she participated in a medical trial of a new, noninvasive rehabilitative device that can deliver more electrical stimulation than similar devices without harming the user. For Reid, use of the device has led to small improvements in her ability to use her hands, and meaningful changes to her daily life.

“Everyone thinks with spinal injury all you want to do is be able to walk again, but if you’re a tetraplegic or quadriplegic, what matters most is working hands,” said Reid, a columnist for The Times, as part of a press briefing. “There’s no miracles in spinal injury, but tiny gains can be life-changing.”

For the study, Reid used a new noninvasive therapeutic device produced by Onward Medical. The device, ARC-EX (“EX” indicating “external”), uses electrodes placed along the spine near the site of injury—in the case of quadriplegia, the neck—to promote nerve activity and growth during physical-therapy exercises. The goal is to not only increase motor function while the device is attached and operating, but the long-term effectiveness of rehabilitation drills. A study focused on arm and hand abilities in patients with quadriplegia was published 20 May in Nature Medicine.

Researchers have been investigating electrical stimulation as a treatment for spinal cord injury for roughly 40 years, but “one of the innovations in this system is using a very high-frequency waveform,” said coauthor Chet Moritz, a neurotechnologist at the University of Washington. The ARC-EX uses a 10-kilohertz carrier frequency overlay, which researchers think may numb the skin beneath the electrode, allowing patients to tolerate five times as much amperage as from similar exploratory devices. For Reid, this manifested as a noticeable “buzz,” which felt strange, but not painful.

The study included 60 participants across 14 sites around the world. Each participant undertook two months of standard physical therapy, followed by two months of therapy combined with the ARC-EX. Although aspects of treatment such as electrode placement were fairly standardized, the current amplitude was personalized to each patient, and sometimes individual exercises, said Moritz.

The ARC-EX uses a 10-kilohertz current to provider stronger stimulation for people with spinal cord injuries.

Over 70 percent of patients showed an increase in at least one measurement of both strength and function between standard therapy and ARC-EX therapy. These changes also meant that 87 percent of study participants noted some improvement in quality of life in a followup questionnaire. No major safety concerns tied to the device or rehabilitation process were reported.

Onward will seek approval from the U.S. Food and Drug Administration for the device by the end of 2024, said study coauthor Grégoire Courtine, a neuroscientist and cofounder of Onward Medical. Onward is also working on an implantable spinal stimulator called ARC-IM; other prosthetic approaches, such as robotic exoskeletons, are being investigated elsewhere. ARC-EX was presented as a potentially important cost-accessible, noninvasive treatment option, especially in the critical window for recovery a year or so after a spinal cord injury. However, the price to insurers or patients of a commercial version is still subject to negotiation.

The World Health Organization says there are over 15 million people with spinal cord injuries. Moritz estimates that around 90 percent of patients, even many with no movement in their hands, could benefit from the new therapy.

Dimitry Sayenko, who studies spinal cord injury recovery at Houston Methodist and was not involved in the study, praised the relatively large sample size and clear concern for patient safety. But he stresses that the mechanisms underlying spinal stimulation are not well understood. “So far it’s literally plug and play,” said Sayenko. “We don’t understand what’s happening under the electrodes for sure—we can only indirectly assume or speculate.”

The new study supports the idea that noninvasive spinal cord stimulation can provide some benefit to some people but was not designed to help predict who will benefit, precisely how people will benefit, or how to optimize care. The study authors acknowledged the limited scope and need for further research, which might help turn currently “tiny gains” into what Sayenko calls “larger, more dramatic, robust effects.”




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Bionic Eye Gets a New Lease on Life



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.”




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Next-Gen Brain Implant Uses a Graphene Chip



A Barcelona-based startup called Inbrain Neuroelectronics has produced a novel brain implant made of graphene and is gearing up for its first in-human test this summer.

The technology is a type of brain-computer interface. BCIs have garnered interest because they record signals from the brain and transmit them to a computer for analysis. They have been used for medical diagnostics, as communication devices for people who can’t speak, and to control external equipment, including robotic limbs. But Inbrain intends to transform its BCI technology into a therapeutic tool for patients with neurological issues such as Parkinson’s disease.

Because Inbrain’s chip is made of graphene, the neural interface has some interesting properties, including the ability to be used to both record from and stimulate the brain. That bidirectionality comes from addressing a key problem with the metallic chips typically used in BCI technology: Faradaic reactions. Faradaic reactions are a particular type of electrochemical processes that occurs between a metal electrode and an electrolyte solution. As it so happens, neural tissue is largely composed of aqueous electrolytes. Over time, these Faradaic reactions reduce the effectiveness of the metallic chips.

That’s why Inbrain replaced the metals typically used in such chips with graphene, a material with great electrical conductivity. “Metals have Faraday reactions that actually make all the electrons interact with each other, degrading their effectiveness...for transmitting signals back to the brain,” said Carolina Aguilar, CEO and cofounder of Inbrain.

Because graphene is essentially carbon and not a metal, Aguilar says the chip can inject 200 times as much charge without creating a Faradic reaction. As a result, the material is stable over the millions of pulses of stimulation required of a therapeutic tool. While Inbrain is not yet testing the chip for brain stimulation, the company expects to reach that goal in due time.

The graphene-based chip is produced on a wafer using traditional semiconductor technology, according to Aguilar. At clean-room facilities, Inbrain fabricates a 10-micrometer-thick chip. The chip consists of what Aguilar terms “graphene dots” (not to be confused with graphene quantum dots) that range in size from 25 to 300 micrometers. “This micrometer scale allows us to get that unique resolution on the decoding of the signals from the brain, and also provides us with the micrometric stimulation or modulation of the brain,” added Aguilar.

Testing the Graphene-Based BCI

The first test of the platform in a human patient will soon be performed at the University of Manchester, in England, where it will serve as an interface during the resection of a brain tumor. When resecting a tumor, surgeons must ensure that they don’t damage areas like the brain’s language centers so the patient isn’t impaired after the surgery. “The chip is positioned during the tumor resection so that it can read, at a very high resolution, the signals that tell the surgeon where there is a tumor and where there is not a tumor,” says Aguilar. That should enable the surgeons to extract the tumor with micrometric precision while preserving functional areas like speech and cognition.

Aguilar added, “We have taken this approach for our first human test because it is a very reliable and quick path to prove the safety of graphene, but also demonstrate the potential of what it can do in comparison to metal technology that is used today.”

Aguilar stresses that the Inbrain team has already tested the graphene-based chip’s biocompatibility. “We have been working for the last three years in biocompatibility through various safety studies in large animals,” said Aguilar. “So now we can have these green lights to prove an additional level of safety with humans.”

While this test of the chip at Manchester is aimed at aiding in brain tumor surgery, the same technology could eventually be used to help Parkinson’s patients. Toward this aim, Inbrain’s system was granted Breakthrough Device Designation last September from the U.S. Food & Drug Administration as an adjunctive therapy for treating Parkinson’s disease. “For Parkinson’s treatment, we have been working on different preclinical studies that have shown reasonable proof of superiority versus current commercial technology in the [reduction] of Parkinson’s disease symptoms,” said Aguilar.

For treating Parkinson’s, Inbrain’s chip connects with the nigrostriatal pathway in the brain that is critical for movements. The chip will first decode the intention message from the brain that triggers a step or the lifting of the arm—something that a typical BCI can do. But Inbrain’s chip, with its micrometric precision, can also decode pathological biomarkers related to Parkinson’s symptoms, such as tremors, rigidity, and freezing of the gait.

By determining these biomarkers with great precision, Inbrain’s technology can determine how well a patient’s current drug regimen is working. In this first iteration of the Inbrain chip, it doesn’t treat the symptoms of Parkinson’s directly, but instead makes it possible to better target and reduce the amount of drugs that are used in treatment.

“Parkinson’s patients take huge amounts of drugs that have to be changed over time just to keep up with the growing resistance patients develop to the power of the drug,” said Aguilar. “We can reduce it at least 50 percent and hopefully in the future more as our devices become precise.”




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Cat's Eye Camera Can See Through Camouflage



Did that rock move, or is it a squirrel crossing the road? Tracking objects that look a lot like their surroundings is a big problem for many autonomous vision systems. AI algorithms can solve this camouflage problem, but they take time and computing power. A new camera designed by researchers in South Korea provides a faster solution. The camera takes inspiration from the eyes of a cat, using two modifications that let it distinguish objects from their background, even at night.

“In the future … a variety of intelligent robots will require the development of vision systems that are best suited for their specific visual tasks,” says Young Min Song, a professor of electrical engineering and computer science at Gwangju Institute of Science and Technology and one of the camera’s designers. Song’s recent research has been focused on using the “perfectly adapted” eyes of animals to enhance camera hardware, allowing for specialized cameras for different jobs. For example, fish eyes have wider fields of view as a consequence of their curved retinas. Cats may be common and easy to overlook, he says, but their eyes actually offer a lot of inspiration.

This particular camera copied two adaptations from cats’ eyes: their vertical pupils and a reflective structure behind their retinas. Combined, these allowed the camera to be 10 percent more accurate at distinguishing camouflaged objects from their backgrounds and 52 percent more efficient at absorbing incoming light.

Using a vertical pupil to narrow focus

While conventional cameras can clearly see the foreground and background of an image, the slitted pupils of a cat focus directly on a target, preventing it from blending in with its surroundings. Kim et al./Science Advances

In conventional camera systems, when there is adequate light, the aperture—the camera’s version of a pupil—is small and circular. This structure allows for a large depth of field (the distance between the closest and farthest objects in focus), clearly seeing both the foreground and the background. By contrast, cat eyes narrow to a vertical pupil during the day. This shifts the focus to a target, distinguishing it more clearly from the background.

The researchers 3D printed a vertical slit to use as an aperture for their camera. They tested the vertical slit using seven computer vision algorithms designed to track moving objects. The vertical slit increased contrast between a target object and its background, even if they were visually similar. It beat the conventional camera on five of the seven tests. For the two tests it performed worse than the conventional camera, the accuracies of the two cameras were within 10 percent of each other.

Using a reflector to gather additional light

Cats can see more clearly at night than conventional cameras due to reflectors in their eyes that bring extra light to their retinas.Kim et al./Science Advances

Cat eyes have an in-built reflector, called a tapetum lucidum, which sits behind the retina. It reflects light that passes through the retina back at it, so it can process both the incoming light and reflected light, giving felines superior night vision. You can see this biological adaptation yourself by looking at a cat’s eyes at night: they will glow.

The researchers created an artificial version of this biological structure by placing a silver reflector under each photodiode in the camera. Photodiodes without a reflector generated current when more than 1.39 watts per square meter of light fell on them, while photodiodes with a reflector activated with 0.007 W/m2 of light. That means the photodiode could generate an image with about 1/200th the light.

Each photodiode was placed above a reflector and joined by metal electrodes to create a curved image sensor.Kim et al./Science Advances

To decrease visual aberrations (imperfections in the way the lens of the camera focuses light), Song and his team opted to create a curved image sensor, like the back of the human eye. In such a setup, a standard image sensor chip won’t work, because it’s rigid and flat. Instead it often relies on many individual photodiodes arranged on a curved substrate. A common problem with such curved sensors is that they require ultrathin silicon photodiodes, which inherently absorb less light than a standard imager’s pixels. But reflectors behind each photodiode in the artificial cat’s eye compensated for this, enabling the researchers to create a curved imager without sacrificing light absorption.

Together, vertical slits and reflectors led to a camera that could see more clearly in the dark and isn’t fooled by camouflage. “Applying these two characteristics to autonomous vehicles or intelligent robots could naturally improve their ability to see objects more clearly at night and to identify specific targets more accurately,” says Song. He foresees this camera being used for self-driving cars or drones in complex urban environments.

Song’s lab is continuing to work on using biological solutions to solve artificial vision problems. Currently, they are developing devices that mimic how brains process images, hoping to one day combine them with their biologically-inspired cameras. The goal, says Song, is to “mimic the neural systems of nature.”

Song and his colleague’s work was published this week in the journal Science Advances.

This article appears in the November 2024 print issue.




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The post Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement appeared first on MedCity News.




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The post AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges?  appeared first on MedCity News.




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The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.




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Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence

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The post Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence appeared first on MedCity News.




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A Sneak Peek of INVEST 2025 Agenda

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Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.

The post Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors appeared first on MedCity News.





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Pew Urges Federal Government to Prioritize Better Exchange of Health Data

The Pew Charitable Trusts sent comments Jan. 4 to the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) urging them to support the easy exchange of individuals’ health records through a pair of regulations.




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State Initiatives Pivot to Address Public Health Challenges During Pandemic

Research has consistently demonstrated strong links between people’s health and societal sectors such as employment, community development, education, housing, and transportation.




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Diagnostic Test Regulation Should Rank High on Agenda of New Congress

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.




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Clinical Lab Tests Need Stronger FDA Oversight to Improve Patient Safety

In vitro diagnostics (IVDs) play an indispensable role in modern medicine. Health care providers routinely rely on these tests—which analyze samples such as blood or saliva—to help diagnose conditions and guide potentially life-altering treatment decisions. In 2017, for example, clinicians ordered blood tests during about 45% of emergency room visits in the United States, according to the Centers...




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Extended Medicaid Coverage Would Help Postpartum Patients With Treatment for Opioid Use Disorder

Between 1999 and 2014, opioid use disorder (OUD) among pregnant women more than quadrupled, risking the health of the women—before and after giving birth—and their infants. As states grapple with COVID-19’s exacerbation of the opioid crisis, several are taking innovative steps to address the needs of high-risk groups, including low-income, postpartum patients with OUD.




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Despite COVID-19 Challenges Dental Therapy Had a Watershed 2020 and Is Poised to Grow

2020 was a difficult year for dental providers as the COVID-19 pandemic swept across the country. When stay-at-home orders went into effect in the spring, dental offices closed their doors to all but emergency patients.




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Pain Management in Crisis: Why Hospitals Are Limiting Pain Medications and What This Means for Patients

Hospitals across the U.S. have significantly restricted the use of pain medications containing narcotics. This shift comes amid […]

The post Pain Management in Crisis: Why Hospitals Are Limiting Pain Medications and What This Means for Patients appeared first on World of DTC Marketing.






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Create Halloween images and learn SAS basics

Learn how to take simple x/y coordinates, and create map polygons shaped like holiday images, that can be plotted using SAS/Graph's PROC GMAP.




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Statistical Model Building for Large, Complex Data: Five New Directions in SAS/STAT Software

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




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SAS Samples62362: Estimate and test differences, ratios, contrasts, or other functions of means in generalized linear models




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McDonald's E. coli crisis reveals why vegetable contamination is harder problem than tainted beef

NEW YORK – Moves by major US fast-food chains to temporarily scrub fresh onions off their menus on Oct 24, after the vegetable was named as the likely source of an E. coli outbreak at McDonald’s, laid bare the recurring nightmare for restaurants: Produce is a bigger problem for restaurants to keep free of contamination than beef. Onions are likely the culprit in the McDonald’s E. coli outbreak across the Midwest and some Western states that has sickened 49 people and killed one, the US Department of Agriculture said late on Oct 23. The company pulled the Quarter Pounder off its menu at one-fifth of its 14,000 US restaurants. In past years, beef patties dominated the dockets of food-borne-illness lawyers, before US federal health regulators cracked down on beef contamination after an E. coli outbreak linked to Jack in the Box burgers hospitalised more than 170 people across states and killed four. As a result, beef-related outbreaks became much rarer, experts say.




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Thai drama under fire for drugging cat for real in death scene, allegedly causing it seizures

The quest for realism in Thai drama The Empress of Ayodhaya went too far when a cat was reportedly drugged in a poisoning scene. In episode five of the show, the character Indravedi (Fern Nopjira Lerkkajornnamkul) suspects her drink has been drugged, so she asks nanny Thongdee (Ja Molywon Phantara) to test it out on the black feline. The cat can be seen convulsing and retching, and the camera moves to show Indravedi looking concerned, while Thongdee declares that it is dead. The scene caused public outrage with fears that the cat had actually been killed, and calls to ban the period drama were trending on X. On Nov 7, a now-deleted X account reportedly belonging to Ja posted: "The cat didn't actually die. We put it under anaesthesia, but while filming, the cat retched and seized." She and Fern initially thought the cat had actually died while filming and their faces "turned pale", she added.




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South Korean actor Song Jae-rim dies aged 39, celebrities pay tribute

South Korean actor Song Jae-rim died yesterday (Nov 12) at the age of 39. The Seongdong Police Station in Seoul confirmed that he was found deceased in his apartment at around 12.30pm. According to media reports, a friend whom he was supposed to meet for lunch had visited his home and reported the death. A two-page letter was reportedly found at the scene but the cause of death has not been confirmed. A police official, however, stated that there are "no signs of foul play". His wake was held at Yeouido St. Mary’s Hospital Funeral Hall at 5.30pm yesterday. His funeral will be held tomorrow at Seoul City Crematorium. Jae-rim gained popularity after starring in the 2012 drama The Moon Embracing the Sun and the 2014 reality series We Got Married. This year, he starred in two dramas — My Military Valentine and Queen Woo. Following news of his death, comedian Hong Seok-cheon and other celebrities posted tributes to Jae-rim on social media.




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Public service committed to flexible work arrangements to meet workforce's changing needs: Govt

The Public Service has expressed its commitment to implementing flexible work arrangements (FWAs) for its employees, taking into account the workforce's changing needs. In a written answer to a Parliamentary question posed by Choa Chu Kang GRC MP Zhulkarnain Abdul Rahim on Monday (Nov 11), Minister-in-charge of the Public Service Chan Chun Sing said the Government recognises the growing need for FWAs, given Singapore's demographic changes and its ever-changing demands on Singaporeans. Zhulkarnain had asked whether the Civil Service will continue to support flexible working arrangements despite some companies in the private sector requiring employees to work from the office five days a week. Grab Singapore, for example, said it will enforce its five-day return-to-office mandate starting Dec 2, reported CNA. Referencing the Tripartite Guidelines on FWA Requests (TG-FWAR), which will be enforced starting Dec 1, Chan stressed the importance of such arrangements in supporting working caregivers, encouraging workforce re-entry, sustaining labour force participation, and attracting and retaining talent.




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'I just want closure': Qoo10 vendors, customers accept they will likely not get money back

SINGAPORE - When an online retailer began selling his products on e-commerce platform Qoo10 in August 2023, he did not bat an eyelid when it took 30 to 45 days for the platform to disburse his first payout, compared with about three to seven days for other e-commerce sites he was using. But nearly a year later in July, payments owed to his business by Qoo10 had ballooned to about $1.6 million, as the platform’s payment delays exceeded two months and disbursements began trickling in, in smaller amounts. The Singaporean, who wanted to be known only as Mr T and did not wish to divulge what he sold, pulled the plug on his Qoo10 shop this year in the middle of July, and filed a civil claim with the courts. He obtained a default judgment in October for Qoo10 to pay him what he is owed, after the e-commerce site failed to serve a notice of intention to contest or not contest the claim. Mr T, who added that he had borrowed nearly $1 million from banks, friends and relatives to pay his suppliers, said: “I am not holding out hope that I will get much, or any, of my money back from Qoo10... By this point, I just want closure because it’s been so stressful.”




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Words Matter: The Effect of Moral Language on International Bargaining

When states use moral language in a dispute, they reduce the possibility of compromise. The possibility of military escalation, meanwhile, rises in response to moral language when states’ domestic audiences accuse their governments of hypocrisy for their willingness to compromise. The Falkland Islands/Islas Malvinas case explores the theory.




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A US Ambassador Working for Cuba? Charges Against Former Diplomat Victor Manuel Rocha Spotlight Havana's Importance in the World of Spying

Calder Walton writes that if proved, Victor Manuel Rocha's espionage would place him among the longest-serving spies in modern times. Allowing him to operate as a spy in the senior echelons of the U.S. government for so long would represent a staggering U.S. security failure.




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226157: Pakistan accepted U.S. military role in counter-insurgency operations




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153436: Training Pakistan's next generation of military leaders

Pakistan's National Defense University's curriculum is designed to foster national pride, but many of its students and instructors have an anti-American bias.




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223755: Finance minister on Pakistan's budget woes, Tokyo pledges, and U.S. assistance

In a September 3 meeting with the Ambassador, Finance Minister Shaukat Tarin said the GOP had included $2 billion in Tokyo Pledges in its budget but was grappling with a shortfall in actual donor assistance.




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233602: Finance minister Tarin on budgets, CSF dollar fund, and Pakistan's improving economic outlook

Tarin requested that an additional $500 million of U.S. assistance flow through the GOP - in addition to the $174 million already committed - to bolster GOP credibility and allow the GOP to more adequately support its priorities.




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242073: Action request for senior level engagement on terrorism finance

Cutting off the flow of funds to terrorist organizations and achieving stability in Af/Pak are top U.S. priorities.




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236981: U.S. Tauscher engages Rao in strategic security dialogue

While each side adhered to familiar positions, the chemistry between the principals was good and the dialogue was cordial and frank.




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The Kissinger Cables




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NHRC notice to Health Ministry over shortage of HIV drugs




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Data | The NDA juggernaut has halted with the BJP-led alliance losing power in key States

While the BJP-led NDA won resoundingly in the 2019 Lok Sabha election, it has lost power in five major State assemblies since December 2018.




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66% of councillors elected to MCD in 41-70 age group, 53% women: Report

Polling was held on December 4 and the results were announced on Wednesday.




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Data | MLAs in poll-bound Karnataka have average assets worth ₹34.6 crore, highest among all States

MLAs in Karnataka have on average assets worth ₹34.6 crore, the highest among all the States




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Data | BJP had the edge in the recent bipolar contests in Karnataka

Elections in Karnataka have increasingly become bipolar, with 77% of the seats recording bipolar contests in 2018




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Odisha political parties urge ECI to ensure neutrality of government machineries during elections

As many as 3.32 crore voters will cast their votes in 37,809 polling stations across State