FDA Commissioner Speaks on AI in Healthcare

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AI startups in healthcare the development of products aimed at hospital systems has increased $23.2 billion in the past ten years, according to a recent analysis from Flare Capital Partners. Most of the financing $11.5 billion has gone to 324 companies working on solutions that impact clinical care. The flow of venture capital money, the speed of technological advancement and the resources of Big Tech companies such as Microsoft, Amazon And Apple have raised questions about who will really drive the AI ​​regulatory agenda in healthcare: the industry or the FBI?

“There is a risk that the system will exceed its ability to regulate, but it will eventually correct itself,” says FDA commissioner. Robert Califf told reporters last week at an event in Massachusetts. “I can guarantee you that Congress is not going to give us 8,000 more positions to regulate the whole thing, and we can’t just stop it.”

The FDA has given permission 950 Medical devices with AI and machine learning from August 7, of which the majority radiology softwarebut the next generation of medical software devices is about to get more complicated. “It’s going to be very different when you use AI for decision support in healthcare, and there’s a lot more concern about how this can fail,” says Califf. “If you basically leave an AI algorithm sitting there and don’t continually monitor it, it could get a lot better, it could get a lot worse.”

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This is even more worrying with new developments in the field generative AIhe said, which is why there must be “an ecosystem where there is shared responsibility.” Califf specifically called for the need for this healthcare systems to ‘act’. “I don’t know how this is all going to play out in terms of liability,” Califf said. “But I think there are a lot of good reasons for health care systems to worry that if they don’t step up, they will end up taking the blame with these algorithms.”

Also a quick note that Alex Knapp, co-author of InnovationRx, is launching a new newsletter, The prototypedelivering the latest science and emerging technologies to your inbox every Friday morning. Register now!


Ozempic’s price will “very likely” be subject to Medicare negotiations, the report said

Ulrich Otte, Novo Nordisk’s Senior Vice President of Finance & Operations, said Tuesday at the Cantor Global Healthcare Conference that it is “very likely” that Ozempic will be part of the cost negotiations organized by the U.S. Centers for Medicare and Medicaid Services, according to Novo Nordisk. “is ready for that,” Bloomberg reported.

The Centers for Medicare & Medicaid Services can negotiate drug prices directly with pharmaceutical companies through President Joe Biden’s Inflation Reduction Act, and will announce the next group of drugs targeted for price negotiations by February 1, 2025.

Read more here.


Pipeline and deal updates

Sleep disorders: The FDA has granted approval sleep apnea detection function in Apple Watch, which uses the device’s sensors to detect breathing obstructions when the user is sleeping and alert them so they can receive care.

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Brain implants: Synchron, which has developed a brain implant that allows interaction with computer devices, announced that one of its patients with ALS was able to use his implant to control Amazon Alexa.

RNA therapies: Korro Bio has announced that this is the case to collaborate with Novo Nordisk for two rare disease targets due to its RNA editing technology. The deal is worth up to $530 million in milestone payments plus royalties on sales of any drugs developed.

Dermatology: The FDA has approved lebrikizumab-lbkz, marketed by Lilly as Ebglyss, for the treatment of moderate to severe dermatitis.

AI for drug development: Ginkgo Biowerk announced it has launched a protein-sized language model, built in partnership with Google Cloud Consulting, to allow customers to leverage AI insights that leverage Ginkgo’s own private datasets.

Antifungal Treatments: F2G, a pharmaceutical company developing new antifungal treatments, announced it has increased its raise a $100 million funding round.


Witchcraft is big business on Etsy

Despite a nearly decade-long ban on the sale of “metaphysical services,” the $6 billion arts and crafts e-commerce platform is home to thousands of spells sold by its creators. The public records show that some of the most popular spell sellers, who boast hundreds of listings and thousands of mostly five-star reviews, have made hundreds of thousands of dollars on tens of thousands of sales.

Many of these spells promise health benefits – to cure depression and illness, to instantly improve fertility, to ‘ensure successful surgeries’. But they are also typically marketed with a disclaimer stating that they are provided for entertainment purposes only, which gives them legal protection in most states.

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“These are scams,” said Kenny Biddle, principal investigator at the Center of Inquiry, an organization dedicated to defending science. “They’re taking people’s money and they’re going to discourage consumers from looking at science-based medicine, which hurts them.”

Read more here


Other healthcare news

Microplastics found in human brains, study says – after being detected in hearts and blood

Everything you need to know about Listeria outbreaks: As the Boar’s Head plant closes indefinitely

This is where abortion comes up in November – while Nebraska’s measures are upheld in court

FDA approves first hearing aid software for Apple’s AirPods

About Forbes

ForbesRussia’s richest woman has given up a third of her fortune. Then things got deadly.ForbesHow Donald Trump made billions through politicsForbesThe Library of Congress is a training data playground for AI companies

What else we read

Dismembered and rented out, the bodies of the poor suffer a final humiliation in Texas (NBC)

Opioid producer Purdue is bankrupt in the US. Its global counterparts make millions. (The exam)

Arkansas Governor Says Medicaid Extension for New Mothers Not Necessary (KFF Health News)

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