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Around the nation: FDA grants 'breakthrough' status to several new medical devices


FDA has granted "breakthrough" status to several new medical devices for pathology, cancer, and Alzheimer's, in today's bite-sized hospital and health industry news from California and Maryland. 

  • California: The Doctors Company has agreed to purchase specialty insurer ProAssurance for $1.3 billion, creating a combined company with assets of around $12 billion. Under the deal, ProAssurance stockholders will receive $25 in cash per share, a roughly 60% premium on the stock's closing price last week. According to the Wall Street Journal, ProAssurance stockholders still need to approve the deal, but it is expected to close in the first half of 2026. "The addition of ProAssurance to The Doctors Company significantly enhances our ability to serve healthcare professionals now and well into the future," said CEO Richard Anderson. (Hamilton, Wall Street Journal, 3/19)
  • California: Google is planning to expand health-related artificial intelligence (AI) summaries in its search engine. According to Google, AI overviews will now cover "thousands more" health topics and include more countries and languages. The company has also added a separate feature in the search engine called "What People Suggest," designed to allow users to learn information from people with similar medical experiences. "These updates show the potential of AI to transform health outcomes across the globe," said Karen DeSalvo, Google's chief health officer. Some of Google's health-related AI efforts include an AI co-scientist that will act as a "virtual scientific collaborator" for researchers and scientists, and TxGemma, an open AI model that can help researchers make predictions in the drug development process. (Alba, Bloomberg/Modern Healthcare, 3/18)
  • Maryland: Between December and March, FDA granted "breakthrough" status to medical devices from at least 15 companies. One of these devices is PathChat, an AI model for pathology. The chatbot, which was developed by Modella AI, can analyze images, talk with users about a specific case, and produce a pathology report. Other devices that received the breakthrough designation include a breast cancer test from PreludeDx, a lung cancer test from Onc.AI, a breast cancer imaging tool from Lumitron, and an endometrial cancer test from Acrivon Therapeutics. The agency also gave breakthrough status to two blood tests for Alzheimer's. One test was developed by Spear Bio while the other was developed by Beckman Coulter. According to STAT, many of the companies that recently received breakthrough status are small startups, and it is the first time their products have received the designation. (Lawrence, STAT, 3/27)

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