Qnovia wins FDA nod for nicotine inhaler as smoking cessation therapy
October 2, 2024
Qnovia announced that the FDA cleared its investigational new drug (IND) application for the RespiRx smoking cessation inhaler (QN-01).
Qnovia announced that the FDA cleared its investigational new drug (IND) application for the RespiRx smoking cessation inhaler (QN-01).
LEUVEN, Belgium, Oct. 1, 2024 /PRNewswire/ — Relu, a pioneer in artificial intelligence (AI) assisted segmentation for dental labs and software companies, proudly announces the dual achievement of 510(k) clearance by the U.S. Food and Drug Administration (FDA) and CE Mark approval by an EU Notified Body. These regulatory milestones authorize the commercial distribution of the Relu® Creator, the cutting-edge dental tool that enables users to create 3D anatomical models from patients in just minutes.
Surmodics (Nasdaq:SRDX) announced today that it received FDA 510(k) clearance for its Pounce XL thrombectomy system.
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.