GE Healthcare gets FDA nod for new PET imaging agent
October 1, 2024
Called Flyrcado, the radiotracer could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.
Called Flyrcado, the radiotracer could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.
Pi-Cardia announced today that the FDA granted clearance for its ShortCut leaflet modification device for TAVR procedures.
Motiva is the first new breast implant to receive premarket approval since 2013, according to Establishment Labs, and enters a market reshaped by safety issues linked to other products.
The IV dislodgement-prevention device is now approved for use with blood or blood product transfusions.
Nevro (NYSE:NVRO) announced today that it received FDA approval for an AI-powered, personalized pain management platform for spinal cord stimulation.
Alesi Surgical has received FDA 510(k) clearance of its Ultravision2 IonPencil for cutting and coagulating soft tissue in open surgery while managing surgical smoke.
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.