Neuralink wins FDA breakthrough nod for vision-restoring implant
September 18, 2024
Neuralink announced on social media that it received FDA breakthrough device designation for its vision-restoring Blindsight implant.
Neuralink announced on social media that it received FDA breakthrough device designation for its vision-restoring Blindsight implant.
GE HealthCare (Nasdaq: GEHC)+
announced today that the FDA has cleared its new imaging tool to assess people with potential Alzheimer’s disease.
Forest Devices announced today that it received FDA 510(k) clearance for its SignalNED Model RE system for brain state analysis.
Boston Scientific (NYSE: BSX)+
announced today that it received FDA approval to expand the indication for its current-generation Ingevity+ pacing leads.
Philips (NYSE: PHG)+
announced today that it introduced the FDA-approved, 160 cm version of its LumiGuide endovascular navigation wire.
Commercial partner Ascensia is in discussions with insulin pump manufacturers to create an automated insulin delivery system.
Biotronik announced today that it received FDA approval for its Selectra 3D catheter and Solia S lead for use in left bundle branch area pacing (LBBAP).
SamanTree Medical announced today that it received FDA 510(k) clearance for its Histolog scanner for tissue imaging.
SILVER SPRING, Md., Sept. 12, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones. Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.
Hinge Health announced that it launched its Enso 3 FDA-cleared wireless device for reducing musculoskeletal pain.