Neuralink's 'breakthrough device' clearance from FDA does not …
WEB2 days ago · Neuralink, the Elon Musk-owned brain-computer interface company, on Tuesday received "breakthrough device" clearance from the FDA. But this does not mean
STAT's Breakthrough Device Tracker updates: knee implant, heart …
WEB15 hours ago · The latest medical devices to receive breakthrough status from the Food and Drug Administration range across conditions, with several treating cardio and neurovascular conditions. The FDA’s ...
Neuralink 'Blindsight' Brain Implant Gets FDA 'Breakthrough Device…
WEB11 hours ago · The device is a variant of Neuralink's brain implant technology, in this case designed to "enable even those who have lost both eyes" to see, according to owner Elon Musk. Separately, progress is reported in a gene …
FDA gives special designation to Neuralink 'Blindsight'
WEB1 day ago · A device that could potentially allow blind people — even those born without the sense of sight — to see has received the U.S. Food and Drug Administration’s “breakthrough device ...
Musk's Neuralink receives FDA's breakthrough device tag for …
WEB2 days ago · Elon Musk's brain-chip startup Neuralink said on Tuesday its experimental implant aimed at restoring vision received the U.S. Food and Drug Administration's "breakthrough device" designation.
Elon Musk's Neuralink receives FDA's 'breakthrough device' …
WEB1 day ago · Elon Musk’s brain chip firm Neuralink has received “breakthrough device” status for an implant aimed at helping blind patients regain their sight, the firm announced Wednesday.
Neuralink Wins Breakthrough-Device FDA Approval for Tackling …
WEB1 day ago · The company celebrated news of its FDA approval with a simple post on X: "We have received Breakthrough Device Designation from the FDA for Blindsight," it said, adding a call for interested ...
Neuralink's 'Blindsight' Device Receives FDA Breakthrough …
WEB1 day ago · Elon Musk's brain-chip company Neuralink has received the FDA’s "breakthrough device" designation for its experimental vision-restoring implant, Blindsight.
Breakthrough Devices Program | FDA
WEBThe Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket...
Updated Final Guidance on Breakthrough Devices Program
WEBSep 14, 2023 · As of June 30, 2023, CDRH has granted Breakthrough Device designation to 831 devices and granted marketing authorization to 77 devices with Breakthrough Device designation.
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