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This week, the FDA issued recommendations for streamlining the clearance process for AI-powered medical devices. The memo announcing this change recognizes that the utilization of AI in devices “is an iterative process” and aims to make it easier to improve software within the regulatory process.
The guidance, which is not legally enforceable but “describe the Agency’s current thinking” suggests that manufacturers could provide a plan for updating AI-powered software in medical devices that would reduce the need to file for a new clearance from the regulatory body. Instead, manufacturers would submit proposed changes to software, a proposal for testing those changes for safety and efficacy and strategies to minimize the risk of updates.
UnitedHealthcare CEO Fatally Shot—Police Believe Attack Was Targeted
The CEO of UnitedHealthcare, Brian Thompson, was fatally shot in Manhattan Wednesday morning, outside of the New York Hilton Midtown, in what police believe was a targeted shooting. UnitedHealth Group was holding a meeting for investors at the New York Hilton Midtown, where the shooting occurred. At the time of this writing, law enforcement is still looking for the alleged attacker, who fled on a bike after shooting Thompson from a few feet away.
Read more here.
Pipeline & Deal Updates
Cardiovascular: The FDA has approved acoramidis (marketed by BridgeBio as Attruby) for cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis, a condition that can lead to heart failure.
AI For Protein Discovery: Cradle, which has developed an AI-powered platform for protein engineering, raised a $73 million series B led by Index Ventures and Kindred Capital.
Private Equity: Frazier Healthcare Partners closed an oversubscribed $2.3 billion fund, Frazier Healthcare Growth Buyout Fund XI, which it says is “focused on acquiring controlling interests in middle-market healthcare companies.”
Cancer Treatment: Novocure reports that a phase 3 clinical trial of its device that uses electric fields against tumors lengthened the life of pancreatic cancer patients.
Radiopharma: GE Healthcare is taking full ownership of radiopharmaceutical company, Nihon Medi-Physics, taking the 50% stake it doesn’t own from Sumitomo Chemical.
30 Under 30 Healthcare 2025: Advancing AI, Delivering Care And Creating New Therapies
Not all cancers are created equally, which means that how to treat them can depend on a variety of factors. But those specifics aren’t always easy for doctors to find. Enter Anirudh Joshi and his company, Valar Labs. It uses AI to analyze an image of a tumor for patients with bladder cancer, which provides data doctors can use to determine the best way to move forward. “AI is going to completely change and create an abundance of healthcare,” he says. “And this is across all domains, not just for what we do.”
So far, 20 hospitals around the country are using Valar Labs’ software, and next up for the company is training its models to analyze other types of cancer, such as pancreatic cancer and lymphoma. To that end, it’s raised $26 million from venture capitalists so far, and Joshi, 29, says Valar Labs could be “the next billion dollar company in cancer.”
Joshi, along with his cofounders Damir Vrabac, 28, and Viswesh Krishna, 23, are just some of the rising stars on the this year’s 30 Under 30 Healthcare list working to solve some of healthcare’s biggest challenges, from developing new drugs to building new devices to expanding access to care.
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Other Healthcare News
Abortions Fell By Only 2% In Year Roe Was Overturned, CDC Report Shows
Nominee For CDC Director, Weldon, May Push For Big Changes In Vaccine Policy
Weight-Loss Drugs Like Ozempic Would Be Covered By Medicare And Medicaid Under Biden Plan
California Halts Sale Of Raw Farm’s Raw Milk Over Bird Flu Concerns—Here’s What To Know
The Right Sleep Schedule Could Reduce Your Risk Of Heart Disease
Across Forbes
What Else We are Reading
Long a ‘Crown Jewel’ of Government, N.I.H. Is Now a Target (The New York Times)
Scientists confront a mystery: Why have U.S. bird flu cases been so mild? (Stat)
What is ageing? Even the field’s researchers can’t agree (Nature)
