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A brain implant to restore vision loss made by Elon Musk’s Neuralink and several tests to detect infectious diseases are among the latest medical devices to receive “breakthrough” status from the Food and Drug Administration.
The FDA granted breakthrough designation to at least nine medical technology companies between mid-September and December, STAT found. 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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