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Healthcare AI startups developing products for hospital systems have raised $23.2 billion over the past decade, according to a recent analysis by Flare Capital Partners. The largest amount of funding, $11.5 billion, went to 324 companies working on solutions that will impact clinical care. The flow of venture capital money, the speed of technological advancements, and the resources of major tech companies like Microsoft, Amazon, and Apple raise the question of who will actually drive the healthcare AI regulatory agenda: industry or the federal government?
“There is a risk that this system will exceed regulatory capacity, but that will eventually correct itself,” FDA Commissioner Robert Califf told reporters at an event in Massachusetts last week. “Congress is not going to give us another 8,000 positions to regulate the entire system, and there’s nothing we can do to stop it.”
The FDA had approved 950 AI- and machine learning-enabled medical devices as of Aug. 7, the majority of which are radiology software, but the next generation of software medical devices is becoming more complex. “When you use AI for healthcare decision support, it’s a very different situation, and there’s growing concern about how AI can malfunction,” Califf said. “If you essentially leave AI algorithms alone and don’t constantly check them, they can get a lot better or they can get a lot worse.”
Calif said that with new advances in generative AI, this is even more of a concern, which is why we need an “ecosystem of shared responsibility.” Calif specifically noted that the health system needs to “step up.” “I don’t know how all of this is going to play out in terms of responsibility,” Calif said. “But I think there’s good reason to be concerned that if the health system doesn’t step up, we’re going to be held accountable for these algorithms.”
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Ozempic price “highly likely” to be subject to Medicare negotiations, reports say
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Ulrich Otte, Novo Nordisk’s senior vice president for finance and operations, said at the Kantar Global Healthcare conference on Tuesday that it was “highly likely” that Ozempic would be subject to price negotiations organized by the U.S. Centers for Medicare and Medicaid Services, adding that Novo Nordisk was “prepared for that,” Bloomberg reported.
The Centers for Medicare & Medicaid Services, which can negotiate drug prices directly with pharmaceutical companies through President Joe Biden’s Controlling Inflation Act, is scheduled to announce the next group of drugs that will be subject to price negotiations by Feb. 1, 2025.
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Pipeline and Deal Updates
Sleep Disorders: The FDA has approved the Apple Watch’s sleep apnea detection feature, which uses sensors on the device to detect breathing disorders while the user is sleeping and alert the user so they can receive care.
Brain implants: Synchron, a company that has developed a brain implant that allows people to interact with computing devices, announced that one of its ALS patients was able to control Amazon Alexa using the implant.
RNA Therapeutics: Korro Bio announced a collaboration with Novo Nordisk on two rare disease targets with RNA editing technology. The deal is worth up to $530 million in combined milestone payments and royalties on sales of developed medicines.
Dermatology: The FDA approved lebrikizumab-lbkz, marketed by Lilly as Ebglyss, to treat moderate to severe dermatitis.
AI for Drug Development: Ginkgo Bioworks announced the release of a protein large-scale language model, built in collaboration with Google Cloud Consulting, to enable customers to access AI insights powered by Ginkgo’s unique private dataset.
Antifungal Treatment: F2G, a pharmaceutical company developing new antifungal treatments, announced it has closed a $100 million funding round.
Magic is big business on Etsy
Illustration by Cecilia Runxi Chan for Forbes; Photos by Minakrin Ruslan/Getty Images, автор/Getty Images, nullplus/Getty Images, SaintM Photos/Getty Images
Despite a nearly decade-long ban on the sale of “metaphysical services,” the $6 billion arts and crafts e-commerce platform hosts thousands of spells for sale by their creators. Some of the most popular spell sellers, boasting hundreds of products and thousands of five-star reviews, have made hundreds of thousands of dollars from tens of thousands of sales, according to public data.
Many of these spells promise health benefits, such as curing depression or illness, instantly boosting fertility or ensuring the success of surgery. But they are usually sold with a disclaimer that they are for recreational purposes only, and are given legal protection in most states.
“These are scams,” said Kenny Biddle, principal investigator at the Center for Investigative Studies, a science advocacy organization. “They’re trying to get people’s money and to divert consumers away from science-based medicine, and that’s what harms consumers.”
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