The FDA is moving to AI tools, cyber pancreas research, and equality for digital therapies

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New FDA guidelines for artificial intelligence create an uncertain future


The Food and Drug Administration He roamed a week with a few thick documents that have big implications for how he oversees technology in healthcare. The most important is agency Final guidance About the types of decision support programs he intends to organize, explaining Four criteriapictured above, which determines whether things like AI programs that identify medical conditions for doctors are diagnostic devices that should be reviewed by the agency.

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Guidelines Specifically calling out Instruments that alert clinicians to sepsis as requiring agency review. The signal appears to be hardly tangential. Sepsis kills more than 200,000 people in the United States each year and is difficult to detect. STAT has Published multiple investigations It details the shortcomings of a widely used tool developed by epic.

However, it is unclear what effect the guidelines will have on the dozens of tools already on the market. As Casey says, the new rules are for her It received a mixed reception. While one lawyer went so far as to call it illegal, others praised elements of the rules that push vendors to provide clearer labels that explain how AI models are built and validated.

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in another place, FDA report Put the agency’s pre-accreditation program into a state of rest. The goal of the program was to explore a simplified review of companies that could show they have maintained high quality standards, and to address concerns that an unwanted FDA device is Not suitable for the most agile world of software development. Ultimately, regulators decided that while a faster process might be possible and desirable, the existing regulatory framework could not be changed without legislation.

Big new study on electronic pancreas

Since 2016, automated insulin delivery has helped people with type 1 diabetes avoid dangerous fluctuations in their blood glucose. But it is still difficult to use so-called “artificial pancreas” systems, which require careful calculation of carbohydrates to help algorithms calculate the correct insulin dose. Data from the pivotal experiment of a new system of Beta BionicsDespite this, he suggests, patients may be able to give up more power to the devices and still have good glucose control.

The diabetes device company submitted an application to the Food and Drug Administration earlier this year for its iLet bionic pancreas, which only requires the user to provide their weight and qualitative history of whether a meal is high, low or medium carb. “I think about diabetes 24/7, and I think these regimens just allow us to make up for some of that,” said Jane Sher, a pediatric endocrinologist with type 1 diabetes. Read more about racing to rFat Insulin Delivery In Latest Katie.

A look at Akili’s Equity Tracking

To help ensure that treatment for ADHD in video games does not only serve white and wealthy people, Akili Interactive She created an initiative called Fair Benefit, which was presented by company leaders in DTx East this week. As part of this effort, the company records how well the gender, race, ethnicity and income of its users are Food and Drug AdministrationA survey product, EndeavorRx, is appropriate for the target group of children with ADHD. The framework allows the company to analyze decisions such as creating new versions of the game for more types of devices. As expected, when Akili expanded from the original iPad version of the game to the iPhone, the fair interest points increased. They assumed that the expansion of Android phones would have a similar effect, but it didn’t. This is because even though Android users were on lower incomes, they were more likely to be men.

“This just highlights that even the sort of simple choices we make, like expanding to Android can have complex impacts on how that impacts equity in your patient base,” said the senior director of data science. Andy Houser.

The company is also studying whether different groups are using the product as intended and will eventually study whether all groups are getting positive results. It is worth noting that the company is studying the issues before the application is widely used in the market.

Industry news

  • Based on grow stable of consumer health devices, Amazon Announced Halo Rise, a new bedside sleep tracker and wake-up light. you will remember The Google Launched Tracking sleep at the Nest Hub last year.
  • Ripplewhich hopes to improve mental health care for seniors, has raised a massive initial round of $32 million led by ARCH Venture Partners And the general catalyst. GVAnd the F Prime CapitalAnd the Mass General Brigham VenturesShare too.
  • Grocery delivery company Instacart It follows a review of tech and retail companies hoping to make their mark on health. Very intuitive name Health Instacart It was described as a broad-based initiative including “product innovations, new partnerships, cutting-edge research and policy advocacy”, targeting “food security, making healthy choices easier, and food as medicine”.
  • Mayo Clinic published new search About an AI scan tool that reads an electrocardiogram to detect atrial fibrillation.
  • headspace health Launch a program Invite external researchers to submit project proposals examining the company’s products.

personal file

  • Babylon health hired Andrew Heine As Vice President to lead the company’s expansion abroad. Hein joins from Ernst & Young.
  • therapeutic chatbot company Woebot’s health hired Brad Gesder As Chief Commercial Officer. Previously, he was Global Head of Digital Innovation and Patient Services at SanofiImmunology.

what we read

    • Can a telehealth startup add a layer of support to pregnancy care?, The New York Times
    • Virtual drug screening identifies potential new antidepressants in LSD-like molecules, STAT
    • Healthy digital twins as tools for precision medicine: Computation, implementation, and regulation considerations. Digital Medicine NPJ

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