A disease detection chatbot powered by generative AI and four cancer tests are among the latest medical devices to receive “breakthrough” status from the Food and Drug Administration.
The FDA granted breakthrough designation to devices from at least 15 medical technology companies between December and mid-March, STAT found. You can learn more about these, as well as other devices that have so far received the designation, using STAT’s Breakthrough Device Tracker.
The agency’s breakthrough devices program is immensely popular with device makers, who can tout the designation in meetings with funders and leverage it to smooth the path toward Medicare reimbursement. The benefit of the program, which launched in 2017, is less clear for patients.
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