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Healthcare AI startups developing products geared towards hospital systems have raised $23.2 billion over the past decade, according to a recent analysis by Flare Capital Partners. The biggest chunk of funding at $11.5 billion has gone to 324 companies working on solutions that impact clinical care. The flow of venture capital money, speed of technology advancement and the resources of Big Tech companies like Microsoft, Amazon and Apple have raised questions about who’s really going to drive the healthcare AI regulatory agenda: industry or the feds?
“There is a risk that the system’s going to outrun the ability to regulate it, but it will eventually self-correct,” FDA Commissioner Robert Califf told reporters at an event in Massachusetts last week. “I can guarantee you 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 authorized 950 AI and machine-learning-enabled medical devices as of August 7 with the majority of them being radiology software, but the next generation of software medical devices is about to get more complicated. “It gets very different when you’re using AI for decision support for healthcare, and there’s a lot more concern there about how it can go akilter,” said Califf. “If you basically leave an AI algorithm in place and don’t constantly check on it, it can get a lot better, it can get a lot worse.”
This is even more concerning with new advances in generative AI, he said, which is why there needs to be “an ecosystem where there’s shared accountability.” Califf specifically called out the need for health systems to “step up.” “I don’t know how all this is going to play out with regard to liability,” said Califf. “But I think there’s a lot of good reason for health systems to be concerned that if they don’t step up, they’re going to end up holding the bag on the liability with these algorithms.”
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Ozempic’s Price ‘Very Likely’ To Be Subject Of Medicare Negotiations, Report Says
Ulrich Otte, Novo Nordisk’s senior vice president of finance & operations, said at the Cantor Global Healthcare Conference on Tuesday that it is “very likely” Ozempic will be part of cost negotiations organized by the US Centers for Medicare and Medicaid Services, adding Novo Nordisk “is ready for that,” Bloomberg reported.
The Centers for Medicare & Medicaid Services can directly negotiate with pharmaceutical companies over drug prices through President Joe Biden’s Inflation Reduction Act, and will announce its next group of drugs designated for price negotiations by Feb. 1, 2025.
Read more here.
Pipeline & Deal Updates
Sleep Disorders: The FDA cleared the sleep apnea detection function in Apple Watch, which uses the device’s sensors to detect breathing obstructions when the user is asleep and alert them to that so they can obtain care.
Brain Implants: Synchron, which has developed a brain implant that allows interaction with computing devices, announced that one of its patients with ALS was able to use his implant to control Amazon Alexa.
RNA Therapies: Korro Bio announced that it’s partnering with Novo Nordisk on two rare disease targets for its RNA editing technology. The deal is valued 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 Bioworks announced it’s launched a protein large language model built in collaboration with Google Cloud Consulting for customers to use AI insights that utilize Ginkgo’s own private datasets.
Antifungal Treatments: F2G, a pharma company developing new antifungal treatments, announced that it has raised a $100 million financing round.
Witchcraft Is Big Business On Etsy
Despite a near decade-long ban on the sale of “metaphysical services,” the $6 billion arts and crafts e-commerce platform hosts thousands of spells being sold by its creators. Its public data shows that some of its most popular spell sellers, who boast hundreds of offerings and thousands of largely 5-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 disease, to immediately enhance fertility, to “ensure successful surgeries.” But they’re also typically marketed with a disclaimer noting they are offered for entertainment purposes only, which provide them legal protection in most states.
“These are scams,” said Kenny Biddle, the chief investigator for the Center of Inquiry, an organization devoted to defending science. “They’re taking money from people and they’re going to keep consumers from looking at science-based medicine, which is harming them.”
Read more here
Other Healthcare News
Microplastics Found In Human Brain, Study Says—After Being Detected In Hearts, Blood
Everything To Know About The Listeria Outbreaks—As Boar’s Head Plant Closes Indefinitely
Here’s Where Abortion Is On The Ballot In November—As Nebraska Measures Upheld In Court
FDA Approves First Hearing Aid Software For Apple’s AirPods
Across Forbes
What Else We are Reading
Cut up and leased out, the bodies of the poor suffer a final indignity in Texas (NBC)
In the US, opioid-maker Purdue is bankrupt. Its global counterparts make millions. (The Examination)
Arkansas’ Governor Says Medicaid Extension for New Moms Isn’t Needed (KFF Health News)
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