Breaking News

Mayo Clinic studies the Apple Watch, Abbott's leadless pacemaker cleared by FDA, & a chart of the digital health world

July 6, 2023
Health Tech Correspondent
Good morning health tech readers!  We're back from the holiday with a number of interesting digital health nuggets. Reach me at mario.aguilar@statnews.com.

DIgital Health

Charting the wide world of digital healthScreen Shot 2023-07-05 at 8.12.38 PM

Digital health is an incredibly broad term that can refer to a range of technologies touching very different parts of health care. The chart above, created by consultancy Health Advances, breaks the world of digital health into a series of discrete categories. 

The chart also has an agenda: It's from a report sponsored by the Digital Therapeutics Alliance, and digital therapeutics, of course, gets its own category. Still, the chart does an admirable job of capturing the range of efforts in a way that's easier to process than some of the sprawling industry maps you'll occasionally see circulating. What do you all think? Email me!


Research

New study to test targeted approach to Apple Watch A-fib screening

The Apple Watch enables users to monitor themselves for signs of atrial fibrillation, which is no doubt catching asymptomatic cases that were undiagnosed. That's good because catching A-fib allows doctors to take steps to prevent strokes. Still, Apple's technology also carries the risk of false positives, which some speculate in a population of millions of mostly healthy users may result in lots of people seeking expensive care they don't need.

A forthcoming study by researchers at Mayo Clinic aims to see if narrowing the population screened by the Apple Watch to focus on the most vulnerable could offer a path forward. The new work builds on previous studies. In a 2019 paper, a team led by some of the same researchers showed that artificial intelligence could identify people at high risk for A-fib from apparently normal electrocardiograms. A follow-up published last year showed that people deemed high risk by the AI were much more likely to screen positive for A-fib when subjected to continuous monitoring for 30 days. 

The new study, set for completion in 2026, will explore if monitoring with an Apple Watch, rather than usual clinical-grade continuous heart monitors, can enable earlier detection of A-fib. Researchers will enroll 2,000 people flagged as high risk by AI and randomize them to receive either an Apple Watch or care as usual. They'll be monitored for a year, which would be very hard to do with a clumsy device with leads attached to the wearer's chest.

"We know that we can risk-stratify a population in terms of atrial fibrillation risk, but what we don't know is what is the most effective way to identify those patients who have atrial fibrillation and get them the treatment they might need," said Peter Noseworthy, a cardiac electrophysiologist at Mayo Clinic and the study's co-principal investor. He added:  "We'd like to see if we can move A-fib screening out of the realm of medical care and into the realm of wellness and consumer activity."


Medical Devices

FDA clears Abbott's second leadless pacemaker

Abbott's wireless pacemaker system, which is built to treat patients with slow or irregular heart rhythms, was approved by the Food and Drug Administration on Wednesday. The "dual chamber" system contains two triple A battery-sized pacemakers  implanted directly in the right atrium and right ventricle of the heart. Traditional pacemakers sit under the skin and are connected to the heart by leads that can sometimes cause complications and infections.

Vish Charan, Abbott's head of research and development in cardiac rhythm, told STAT's Lizzy Lawrence that while physicians are still getting used to the leadless technology, the company "really believe[s] the future is going to be leadless." 

Abbott earned approval for its single chamber system in 2022, and the device maker is betting that its new, two-chamber system will enable it to capture a large share of the market. Charan said 80% of pacemaker patients require the double pacemakers. Medtronic, meanwhile, has been selling its own leadless pacemaker since 2016. Boston Scientific is working on developing a similar device as well.



Artificial intelligence

The regulatory challenges posed by large language models

Screen Shot 2023-07-05 at 8.19.39 PM

By now, it's clear that while large language model technologies similar to OpenAI's ChatGPT might be useful for some health care tasks, like drafting clinician emails, their propensity to fabulation make them a risky choice for diagnostic tools and other medical implementations. Authors of a new article in Nature Medicine dive into another challenge: Many use cases, like tools that help doctors make decisions, may require regulatory clearance in both the United States and Europe — which could prove very difficult because of their "inherent limitations" (see above). The authors suggest approaches that could make regulation possible, including making the underlying algorithms and data models available for review or introducing oversight tools that keep tabs on all chats independent of the developer. That sounds like a lot for companies that closely guard their secret technologies, but the authors insist that "the huge efforts applied to training LLMs for creativity and plausibility should equally be applied to providing evidence of safety and validation in medicine."


Chronic diseases

Dexcom's CEO on going after type 2 market

At the American Diabetes Association's annual conference, Dexcom announced plans to release software built to support people who have type 2 diabetes who want to use the company's continuous glucose monitors (CGMs). CGM use is well established among people who have type 1 diabetes because they are useful for directing insulin treatment, but interest in the type 2 community is growing as well. In an interview with Lizzy, CEO Kevin Sayer revealed more about the company's plans for the type 2 product, including its hopes to one day show that it improves clinical outcomes.

"We don't have a big, several-thousand-patient study going on, but there's numerous studies that have been done for the past several years by groups like UnitedHealth Group with the Level2 program, Onduo, Livongo. A number of our partners have been putting this product on people that are using it with type 2 diabetes, non-insulin delivery," he said, noting that these many efforts add up to an "outcomes case."

 
"There may be a day when we run a study to demonstrate very strong outcomes for reimbursement. For now, we just want to get the product out there."

Read more here


More around STAT
Check out more exclusive coverage with a STAT+ subscription
Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

What we're reading

  • ChatGPT app downloads are slowing down, BofA finds, CNBC
  • Masimo proxy battle ends with election of 2 board members from activist investor Politan, Fierce Biotech
  • Daniel Ek's Neko Health raises $65M for preventative healthcare through full-body scans, TechCrunch

  • The 27 best books and podcasts on health and science to check out this summer, STAT

  •  

Thanks for reading! More on Tuesday - Mario

Mario Aguilar covers how technology is transforming health care. He is based in New York.


Enjoying STAT Health Tech? Tell us about your experience
Continue reading the latest health & science news with the STAT app
Download on the App Store or get it on Google Play
STAT
STAT, 1 Exchange Place, Boston, MA
©2023, All Rights Reserved.

No comments