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InnovationRx: FDA Issues New Guidance For AI In Medical Devices

Dec 04, 2024 - forbes.com
The FDA has issued recommendations to streamline the clearance process for AI-powered medical devices, aiming to simplify software improvements within the regulatory process. Manufacturers could provide a plan for updating AI software in medical devices, reducing the need for new clearance from the regulatory body. In other news, Brian Thompson, the CEO of UnitedHealthcare, was fatally shot in a targeted attack in Manhattan.

In the healthcare sector, several developments have been reported. BridgeBio's acoramidis has been approved by the FDA for a condition leading to heart failure, Cradle raised $73 million for its AI-powered protein engineering platform, and Frazier Healthcare Partners closed a $2.3 billion fund. Novocure's device has shown promising results in a clinical trial for pancreatic cancer patients, and GE Healthcare is acquiring full ownership of Nihon Medi-Physics. Valar Labs, a company using AI to analyze tumor images, has raised $26 million and is expanding its models to analyze other types of cancer.

Key takeaways:

  • The FDA has issued recommendations to streamline the clearance process for AI-powered medical devices, suggesting that manufacturers could provide a plan for updating AI-powered software in medical devices to reduce the need for a new clearance from the regulatory body.
  • Brian Thompson, the CEO of UnitedHealthcare, was fatally shot in Manhattan in what police believe was a targeted shooting. The alleged attacker is still at large.
  • Valar Labs, a company that uses AI to analyze images of tumors for patients with bladder cancer, has raised $26 million from venture capitalists. The company's software is currently being used in 20 hospitals around the country.
  • Other healthcare news includes a CDC report showing that abortions fell by only 2% in the year Roe was overturned, a potential push for big changes in vaccine policy by the nominee for CDC Director, and concerns over bird flu leading to the halt of sale of Raw Farm's raw milk in California.
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