MedTech News
Qnovia wins FDA nod for nicotine inhaler as smoking cessation therapy
Qnovia announced that the FDA cleared its investigational new drug (IND) application for the RespiRx smoking cessation inhaler (QN-01).
Relu Secures FDA 510(k) and CE Marking for Revolutionary Dental Software Relu® Creator
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.
FDA clears Surmodics’ Pounce XL thrombectomy system
Surmodics (Nasdaq:SRDX) announced today that it received FDA 510(k) clearance for its Pounce XL thrombectomy system.
GE Healthcare gets FDA nod for new PET imaging agent
Called Flyrcado, the radiotracer could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.
Senseonics, Ascensia launch Eversense 365 year-long CGM in the U.S.
Ascensia Diabetes Care announced today that it launched the Eversense 365 CGM system from Senseonics (NYSE:SENS) in the U.S.
Stevanato Group expands large-volume drug delivery offerings
Stevanato Group announced today that it expanded the capacity of its Vertiva on-body device for subcutaneous large-volume drug delivery.
Johnson & Johnson rolls out next-gen intraocular lens
Johnson & Johnson (NYSE: JNJ)+
announced today that it expanded the rollout of its latest Tecnis Odyssey presbyopia-correcting intraocular lenses (PC-IOLs).
Pi-Cardia wins FDA nod for leaflet modification device that enables TAVR
Pi-Cardia announced today that the FDA granted clearance for its ShortCut leaflet modification device for TAVR procedures.