REMSleep Holdings Inc has received FDA 510(K) clearance for its new DeltaWave nasal pillow CPAP interface mask. The DeltaWave is designed to enhance comfort and maintain natural breathing patterns, aiming to address common issues that lead to therapy discontinuation
ImmersiveTouch announced today that it received FDA 510(k) clearance for its ImmersiveAR augmented reality technology platform.
CAMP HILL, Pa.–(BUSINESS WIRE)–Forma Medical Inc., a leading innovator in medical device technologies, is thrilled to announce the FDA 510(k) clearance for its groundbreaking OptimalMTP® Plating System. This regulatory milestone marks a significant leap forward in MIS (Minimally Invasive Surgery), ushering in a new era of precision and efficiency dedicated to foot and ankle surgery, one of the fastest growing segments in the medical device space.
Orthofix (Nasdaq: OFIX) today announced it received FDA 510(k) clearance for the Fitbone Transport and Lengthening System and reported the first implant of the device.
Cordis announced today that the FDA granted premarket approval (PMA) for its Mynx Control venous vascular closure device (VCD).
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted breakthrough device designation for its pulsed field ablation system. Shares of PLSE rose more than 20% in mid-morning trading on the back of this announcement.
Signum Surgical announced today that the FDA granted de novo clearance for its BioHealx implant for treating anal fistula.
IceCure Medical (Nasdaq:ICCM) announced today that the FDA granted clearance for its next-generation single-probe cryoablation system
Each patch now replaces up to 12 mealtime injections, equaling more than 1,000 fewer injections annually, according to a news release.
SILVER SPRING, Md., June 27, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C.