White House launches covid.gov with testing and treatment resources

The White House has launched covid.gov, a dedicated website for COVID-19 guidance, including resources for treatment and testing. The site is meant to be a “one-stop shop” for all things related to COVID-19, including testing and treatment options, mas…

Google seeks FDA approval for Fitbit’s passive heart rate monitoring tech

Following a large-scale virtual health study, Google has submitted Fitbit’s passive heart rate monitoring algorithm for review by the US Food and Drug Administration. 

The study, which went live in May 2020, was open to all US Fitbit users over the age of 22, and it was designed to test how accurately the device could detect atrial fibrillation, or irregular heart rhythm. The system uses photoplethysmography to passively track the blood flow in a user’s wrist and determine if there are any concerning irregularities. Google said its algorithm correctly identified undiagnosed AFib 98 percent of the time in this study, and the company presented its results to the American Heart Association at its most recent meeting.

Fitbit’s Sense Smartwatch was approved by the FDA in 2020 for its ability to assess AFib using built-in electrocardiogram technology. This method requires active input from the user, while the PPG system heading to the FDA today runs in the background.

In addition to the Fitbit FDA news, Google is rolling out a few other healthcare-related tools. Google Search in the US will soon show available appointment slots with local doctors and clinics when looking for care, with an emphasis on the CVS MinuteClinic.

“While we’re still in the early stages of rolling this feature out, we’re working with partners, including MinuteClinic at CVS and other scheduling solution providers,” Google chief health officer Dr. Karen DeSalvo said. “We hope to expand features, functionality and our network of partners so we can make it easier for people to get the care they need.”

Google is also rolling out “health source information panels” and “health content shelves” on YouTube videos in Japan, Brazil and India this week, in an effort to highlight credible information from legitimate sources.

DeepWell DTx is a therapy-focused game studio from the co-founder of Devolver

Therapy has an engagement problem. Despite the benefits of treatment plans and at-home exercises, people generally resist anything that feels like work, and this impedes the mental-health recovery process across the board. Clinicians have attempted to bridge this gap with various devices and reward systems, but still, it’s often incredibly difficult to motivate patients to help themselves.

Video games have the opposite problem. Players can spend hours immersed in a single digital experience, seated in one spot and lost in their own world, but they’re often branded as “lazy” for this behavior. Video games are widely viewed as a waste of time, even with growing research demonstrating the psychological benefits of play.

So, why not smash these industries together and see what happens? DeepWell Digital Therapeutics is a new video game publisher and developer from Devolver Digital co-founder Mike Wilson and medical device creator Ryan Douglas, and their goal is to alter the way people think about games and mental health. The DeepWell DTx advisory council includes more than 40 medical researchers, doctors and veteran game developers, including Tom Hall (Doom), Zoe Flower (Hellbent Games), Rami Ismail (Nuclear Throne), Lorne Lanning (Oddworld) and American McGee (American McGee’s Alice).

“We fight with engagement all the time,” Douglas said. He worked for years with light therapy and other interventions designed to treat anxiety, depression and stress, but said accessibility and participation were constant battles. “And these [game developers] had cracked that code at a level that they were really hitting hard neurological reward centers in the brain, in a way that the availability to effectively change what people do and think in certain times of mental illness was vastly improved over anything I’d seen before.”

DeepWell DTx
DeepWell DTx

DeepWell DTx isn’t about gamifying therapy tools or building digital experiences based on strict medical templates. Instead, the studio will analyze existing games for potential mental health benefits and, in some cases, work with interested developers to enhance these mechanics. The team will then secure approvals from regulators for these games to treat mental health issues including PTSD, anxiety, depression, OCD and addiction.

This is where Douglas’ expertise comes in. He’s the founder and former CEO of medical device company Nextern and he’s secured FDA approval for more than 25 medical devices over the past 15 years; he knows how to navigate this regulatory process and he sees games as a natural fit. He and Wilson started working on DeepWell about 18 months ago, in the middle of the COVID-19 pandemic.

“There’s a very specific regulatory pathway for this work,” Douglas said. “So, a couple key things — agencies have done a lot of work in the last couple years to figure out how software as a medical device and specifically digital therapeutics are going to work. The FDA has been collaborative in that work. And then in this emergency time, there has been more opportunity to do the work that we need to do to get these in people’s hands as quickly as possible. It’s arduous but not impossible.”

Additionally, DeepWell DTx will provide a framework for players to recognize these benefits as they play — whether that’s a label on the game’s storefront, a welcome screen or another digital signal — allowing them to adjust their mindset before pressing start.

“We’re super excited largely because of some intellectual property Ryan filed long before he met me, a couple years before he met me,” Wilson said. “We believe we’ve got a system built to enable game developers — eventually other media creators, as well — to work their magic and in a way that is already quite beneficial.”

It takes one whole minute before Wilson drops the phrase “digital psychedelics” into the conversation. This is kind of his thing; he’s an evangelist for psychedelics, with endless stories about Burning Man and the personal, therapeutic benefits he’s reaped from trips. Psychedelic therapy was a starting point for Wilson and Douglas, and they’re looking to mimic the perspective-shifting, calming effects of these substances through accessible digital experiences. They’re focused on alleviating a mental health crisis that was exacerbated by the global quarantine, using tools that people already have and naturally reach for.

“While it might not be as powerful as sitting with a macro dose of mushrooms and a couple of therapists, it might not be one session or two sessions or three, but it is an adjunct therapy that is good for you, that you might be way more likely to engage in and that the whole world has access to, even if they don’t have access to health care,” Wilson said. “These will be interventions that are helpful to people that are just paying regular game prices.”

Literally every game is up for review from the DeepWell DTx crew, from platformers and narrative adventures to RPGs and shooters, and interested developers can apply starting today. There’s also an in-house development arm of the DeepWell beast, and its first game is already halfway through development, with a few others in pre-production. The first DeepWell games are due to start rolling out in 2023.

Patient dies two months after groundbreaking pig heart transplant

David Bennett, the first human to successfully undergo a heart transplant involving a genetically modified pig heart, has died, according to The New York Times. He was 57. It’s unclear if his body rejected the organ doctors implanted in January. “There…

Eargo 6: Tiny hearing aids that don’t scrimp on features

In the world of hearing aids, Eargo stands out for a few reasons. Not least because of its different approach, but also because of its rapid, annual release cycle. It’s all part of how Eargo operates more like a technology company instead of a stuffy medical-device provider. This year’s model? It’s number 6, and it’s not a huge leap from last year’s, but it’s still a notable one. One that pushes Eargo ever nearer to feature parity with the competition it seeks to outdo while maintaining its tiny, tiny form factor.

It’s that form factor that is both beneficial and binding. To be clear, “invisible in canal” (IIC) hearing aids are not unique to Eargo, but they do tend to come with tradeoffs such as no Bluetooth connectivity, reduced battery life and, of course, a lack of on-device controls (such as volume). To Eargo’s credit, it has found ways to sidestep most of these challenges with each new product, and this time it’s automatic profile switching – dubbed “Sound Adjust” — that gets crossed off the list of things that an Eargo can’t do.

First, a reminder of some of the things previous models could already do. Despite their size you can configure Eargos via the companion app. Initially, this was limited to placing them in the (Bluetooth-enabled) charging case, but newer models can be adjusted while wearing them thanks to the clever use of ultrasonic commands. You can also switch preset profiles using a gesture (double-tapping your tragus). All Eargos are also rechargeable with a charging case so you don’t need to fiddle with batteries.

More recently, since last year’s model, you’ve been able to customize the audio profile of the hearing aids to match your own unique hearing needs, which is perhaps the most significant update for most people. As a direct-to-customer product there’s usually no audiologist fitting these for you, so the app-based process goes a long way to eliminating that rather obvious negative and probably also does a good job of convincing fence-sitters that these are serious hearing aids and not fancy personal amplifiers (all Eargo products have been FDA approved hearing aids).

Eargo 6 hearing aids with Sound Adjust shown on their packaging with the portable charger.
James Trew / Engadget

When it comes to testing out the new Sound Adjust feature it’s not quite as simple as monitoring the companion app and watching it update as a profile changes. Thanks to how the Eargos communicate with the app (via the aforementioned ultrasound) the phone needs to be very close to the hearing aids with the volume up (above 75 percent) for it to make changes. Of course, that’s just one way. Right now, there’s no real way for the buds themselves to communicate back to the app. So how do we know when the hearing aids change modes?

As a crude test I left the Eargos on the “Normal” preset and then simulated a noisy room by playing some restaurant sounds over a nearby speaker. I can’t be certain what changes the device made, but compared to the same test wearing the previous model (without Sound Adjust) the noise did seem less jarring. The sharp sound of cutlery against plate was more pronounced in the older model than it was in the Eargo 6.

There is another, perhaps more immediately observable difference this time around and that’s the noise reduction, which seems much improved. As before you can decide how much noise reduction to apply from three different settings (low to high) or disable it if you prefer. It’s not obvious how much this feature impacts the battery life. I was able to get a full day’s use out of them with it activated and room to spare, so I don’t see why you wouldn’t use it — it really does make the hearing experience more natural.

These new features definitely add some finesse to the whole experience. They’re also more practical updates, too. There’s a new “mask mode” which, and I mean this optimistically, I hope doesn’t remain useful for much longer but it’s there nonetheless. Another practicality is that the Eargo 6 is rated IPX7 for water resistance: finally, you can take a shower with these things in. With water-resistant earbuds/headphones, stepping into the shower with them on is a novelty, but with a hearing device you want to put on forget about, not having to remove them for a shower just gives you one less thing to worry about.

All these new changes increase the viability of the Eargo 6 as a replacement for whatever legacy device you might be using currently. Or, if you sense you could benefit from hearing assistance but the thought of a trip to the audiologist or haggling with insurance has been putting you off, these are about as easy an option you can find.

Eargo's mobile app running on the iPhone 12.
James Trew / Engadget

I do wish they were a little more comfortable for extended use. In general, they are fine – even for all-day wearing. But some days, my ears can feel a little more blocked than others and when this happens, I can sense some fatigue after a couple of hours with the Eargo inside. This can be further aggravated by eating, which reminds you how connected many of the muscles in our jaw and ear are.

It would also be nice to know when the Eargo have reached their maximum or minimum volume. There are controls in the app for adjusting them together and separately (perfect for my unilateral hearing loss) but I never know when it’s at maximum, so I end up either over pressing the “+” sign to make sure I must be at max when some simple feedback could just solve the mystery. This is obviously a minor nitpick, though it can be useful for helping to get the balance right to avoid going so loud as to create feedback, which does occur at higher volumes (on most hearing aids).

As always, if these sound like they might be helpful to you, you can buy them directly from the Eargo website for $2,950 (financing is available). As to whether this could be covered by your insurance, that’s less clear/something you’ll need to confirm with your provider.

AI discovery could advance the treatment of spinal cord injuries

A combination of AI and robotics might help people recover from spinal cord injuries. A Rutgers-led team has used the technology to stabilize an enzyme, Chondroitinase ABC (ChABC), that can degrade scar tissue from spinal cord injuries and encourage tissue regeneration. Where the enzyme only lasted for a few hours at body temperatures, it now lasts over a week — enough to have a more substantial effect.

The researchers started by using machine learning to identify synthetic copolymers (artificial polymers made from more than one monomer) that would last the longest inside a human. Liquid-handling robotics synthesized the copolymers and conducted the tests. This was one of the “first times” AI and robotics have been used in tandem to produce therapeutic proteins that were effective to such a degree, according to Rutgers assistant professor and lead study investigator Adam Gormley.

The stabilized enzyme doesn’t amount to a functional treatment for spinal cord injuries, at least not yet. The scientists noted their tech pairing created a “promising pathway” toward longer-term tissue regeneration, not the solution itself. Even so, this project highlights one of the advantages of using AI to develop treatments. Algorithms can find compositions that would be difficult or time-consuming to locate for human researchers, making therapies practical where they weren’t an option before.