The U.S. Food and Drug Administration (FDA) has recently designated 11 medical innovations as “breakthrough devices,” a status that fast-tracks their development and review. Among these, Neuralink’s brain implant stands out, aiming to treat paralysis and other neurological conditions. The FDA’s breakthrough device program, established in 2015, has now recognized over 700 devices, with 10% receiving full approval. This year, the FDA has already granted 20 breakthrough designations, showcasing a significant increase in innovative medical technology. Other notable devices include a test for detecting respiratory viruses like influenza and RSV, and a diagnostic tool for identifying pathogens in blood samples. These designations highlight the FDA’s commitment to accelerating the availability of advanced medical technologies to patients.
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