FDA Evolves on AI Tools, Bionic Pancreas Research, and Equity in Digital Therapy

FDA Evolves on AI Tools, Bionic Pancreas Research, and Equity in Digital Therapy

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New FDA guidelines on AI create an uncertain future

The Food and drug administration started the week with a dense handful of documents that have big implications for how he will oversee technology in healthcare. Most important is the agency’s final guidelines on the types of business intelligence software it intends to regulate, setting out four criteria, pictured above, that determine whether things like business intelligence software AIs that flag medical conditions to doctors are considered diagnostic devices that must be reviewed by the agency.


The guidelines specifically call out tools that alert clinicians to sepsis as requiring agency review. The mention seems hardly accidental. Sepsis kills more than 200,000 people in the United States each year and is notoriously difficult to detect. STAT has published several surveys detailing the shortcomings of a widely used tool developed by Epic.

Still, it’s unclear what impact the guidelines will have on dozens of tools that are already on the market. As Casey reports, the new rules have had a mixed reception. While one lawyer went so far as to call them illegal, others applauded elements of the rules that push vendors to provide clearer labels explaining how AI models were built and validated.


Elsewhere, an FDA report ended the agency’s software pre-certification program. The program aimed to explore a streamlined exam for companies that could show they maintained high quality standards, addressing concerns that the FDA’s clunky apparatus is ill-suited to the more agile world of software development. Ultimately, regulators determined that while a faster process may be feasible and desirable, the existing regulatory framework cannot be changed without legislation.

A big new study on a bionic pancreas

Since 2016, automated insulin delivery has been helping people with type 1 diabetes avoid dangerous fluctuations in their blood sugar. But so-called “artificial pancreas” systems are still difficult to use, requiring careful carbohydrate counting to help algorithms calculate the right insulin dose. Data from the pivotal trial of a new system of Bionic Betahowever, suggests that patients might be able to give machines more power and still achieve good blood sugar control.

The diabetes device company submitted an application to the FDA earlier this year for its iLet bionic pancreas, which only requires a user to submit their weight and quality log of whether a meal is high, low or medium in carbohydrates. “I think about my diabetes 24/7, and I think these systems just allow us to offset some of that,” said Jen Sherr, a pediatric endocrinologist who also has type 1 diabetes. Learn more about the race for robotic insulin delivery in Katie’s latest post.

A look at Akili’s stock tracking

To help ensure that his video game treatment for ADHD doesn’t just serve white, wealthy people, interactive mind created an initiative called Equitable Benefit, which business leaders presented to DTx East this week. As part of this effort, the company tracks the extent to which the gender, race, ethnicity, and income of users of its FDA-licensed product, EndeavorRx, aligns with the target population of children with ADHD. The framework allows the company to analyze decisions such as creating new versions of the game for more device types. As expected, when Akili moved from the original iPad version of the game to the iPhone, his fair advantage score increased. They assumed that extending to Android phones would have a similar effect, but that’s not the case. Indeed, although Android users had lower incomes, they were also more likely to be male.

“It just highlights that even very simple choices we make, like extending to Android, can have complicated effects on how it affects the fairness of your patient base,” the chief science officer said. Datas. Andy Heusser.

The company is also looking at whether different groups are using the product as intended and will eventually investigate whether all groups are seeing positive results. It should be noted that the company is considering the issues before the app is widely used in the market.

Industry News

  • Building on its growing line of consumer healthcare devices, Amazon announced Halo Rise, a new bedside sleep tracker and wake-up light. you will remember Google launched sleep tracking in its Nest Hub last year.
  • Ripplewhich hopes to improve mental health care for the elderly, has raised a whopping $32 million funding round led by ARCH Venture Partners and General Catalyst. GV, F-Prime Capitaland Mass General Brigham Venturesalso participated.
  • Grocery delivery company instagram follows a parade of tech and retail companies hoping to make their mark on health. The very intuitively named Instacart Health is presented as a far-reaching initiative comprising “product innovations, new partnerships, cutting-edge research and policy advocacy”, targeting “nutrition security, facilitating healthier choices and food as medicine”.
  • Mayo Clinic published new research on an AI screening tool that reads electrocardiograms to detect atrial fibrillation.
  • Headspace Health launched a program inviting outside researchers to submit project proposals studying the company’s products.

Personal file

  • Babylon Health hiring Andrew Hine as Vice President to lead the company’s overseas expansion. Hine joins from Ernest and Young.
  • Therapeutic chatbot company Woebot Health hiring Brad Gescheider as commercial director. Previously, he was Global Head of Digital Innovation and Patient Services for Sanofithe immunology activity of .

What we read

    • Can a Telehealth Startup Add a Layer of Support to Pregnancy Care?, New York Times
    • Virtual drug screening identifies possible new antidepressants in LSD, STAT-like molecules
    • Digital Health Twins as Tools for Precision Medicine: Considerations for Computation, Implementation, and Regulation, NPJ Digital Medicine

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