This week, the FDA issued new recommendations to streamline the clearance process for AI-powered medical devices. Recognizing that the development of AI in medical devices is “an iterative process,” the guidance aims to simplify the process of improving software within regulatory frameworks.
Although not legally binding, the guidance reflects the FDA’s current perspective. It suggests that manufacturers submit a comprehensive plan for updating AI-powered software in medical devices. This plan would reduce the need for filing new clearance applications by outlining proposed software changes, testing protocols to ensure safety and efficacy, and risk mitigation strategies for updates.
Pipeline & Deal Highlights
Cardiovascular: The FDA approved acoramidis (marketed by BridgeBio as Attruby) for the treatment of cardiomyopathy caused by wild-type or variant transthyretin-mediated amyloidosis, a condition linked to heart failure.
AI in Protein Discovery: Cradle, an AI-driven protein engineering platform, raised $73 million in a Series B funding round led by Index Ventures and Kindred Capital.
Private Equity: Frazier Healthcare Partners closed its oversubscribed $2.3 billion fund, Frazier Healthcare Growth Buyout Fund XI, which focuses on acquiring controlling interests in middle-market healthcare companies.
Cancer Treatment: Novocure reported that its phase 3 clinical trial demonstrated that its tumor-treating electric field device extended the survival of pancreatic cancer patients.
Radiopharma: GE Healthcare has acquired full ownership of Nihon Medi-Physics, a radiopharmaceutical company, by purchasing the remaining 50% stake from Sumitomo Chemical.
Spotlight on AI in Healthcare
Not all cancers are alike, and treatment approaches often depend on specific tumor characteristics, which are not always easy for doctors to identify. Valar Labs, founded by Anirudh Joshi, leverages AI to analyze tumor images for bladder cancer patients, providing actionable data for tailored treatments. “AI is poised to transform healthcare and create an abundance of solutions across all domains,” says Joshi.
Currently, Valar Labs’ software is used in 20 hospitals nationwide. The company is expanding its AI models to address other cancers, including pancreatic cancer and lymphoma. To support these efforts, Valar Labs has secured $26 million in venture funding. Joshi, 29, envisions Valar Labs becoming “the next billion-dollar company in cancer.”
Joshi and his co-founders, Damir Vrabac (28) and Viswesh Krishna (23), are among the rising stars on this year’s 30 Under 30 Healthcare list, which highlights innovators tackling healthcare’s toughest challenges—from developing novel drugs to enhancing access to care.
