MedTech News
Neuralink wins FDA breakthrough nod for vision-restoring implant
Neuralink announced on social media that it received FDA breakthrough device designation for its vision-restoring Blindsight implant.
GE HealthCare picks up FDA nod for new brain imaging tool for Alzheimer’s
GE HealthCare (Nasdaq: GEHC)+
announced today that the FDA has cleared its new imaging tool to assess people with potential Alzheimer’s disease.
FDA clears EEG for brain analysis from Forest Devices
Forest Devices announced today that it received FDA 510(k) clearance for its SignalNED Model RE system for brain state analysis.
FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
Boston Scientific (NYSE: BSX)+
announced today that it received FDA approval to expand the indication for its current-generation Ingevity+ pacing leads.
FDA approves enhanced Philips LumiGuide endovascular navigation wire
Philips (NYSE: PHG)+
announced today that it introduced the FDA-approved, 160 cm version of its LumiGuide endovascular navigation wire.
Edwards launches Sapien 3 valve with Alterra prestent in Europe
Edwards Lifesciences (NYSE: EW)+
announced that it launched its Sapien 3 transcatheter pulmonary valve implant (TPVI) system with Alterra adaptive prestent in Europe.
Medtronic unveils novel approach to studying adaptive deep brain stim for Parkinson’s
Medtronic (NYSE: MDT)+
today announced the publication of its novel approach to studying adaptive deep brain stimulation (aDBS).
Senseonics receives FDA clearance for one-year CGM
Commercial partner Ascensia is in discussions with insulin pump manufacturers to create an automated insulin delivery system.