WARSAW, Ind., Dec. 4, 2024 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Persona® SoluTion™ Porous Plasma Spray (PPS®) Femur, a total knee implant component offering an alternative for patients with sensitivities to bone cement and/or metal.
WUHAN, China, Dec. 4, 2024 /PRNewswire/ — Rhein Laser Technologies Co., Ltd. is proud to announce that its UroFiber® 60Q SuperPulsed Thulium Fiber Laser System received FDA 510(k) clearance (K242293) on November 19, 2024, marking a significant breakthrough in surgical laser development.
NEWPORT BEACH, Calif., Dec. 3, 2024 /PRNewswire/ — Wave Neuroscience, a leader in personalized non-invasive neuromodulation technology, today announced that its proprietary Magnetic EEG Resonance Therapy (MeRT) system has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for adjunctive treatment of Post-Traumatic Stress Disorder (PTSD).
InnoCare Urologics announced today that it received FDA 510(k) clearance for its novel urinary safety catheter.
Beacon Biosignals announced today that it received FDA authorization for a new update to its Dreem 3S wearable sleep monitoring headband.
Nonin Medical has won FDA 510(k) clearance for its first over-the-counter fingertip pulse oximeter, the TruO2 OTC.
IRVINE, Calif., Dec. 2, 2024 /PRNewswire/ — Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of Johnson & Johnson MedTech, today announced the U.S. Food and Drug Administration (FDA) approved MENTOR™ MemoryGel™ Enhance Breast Implants for primary and revision reconstruction breast surgery in post-mastectomy women.
CHICAGO, Dec. 2, 2024 /PRNewswire/ — ScreenPoint Medical is showcasing a new FDA clearance for innovative new capabilities of its industry leading Breast AI Transpara here at the 110th Annual Radiological Society of North America (RSNA) meeting, December 1-4, 2024 (South Hall #5316)
PRINCETON, N.J., Dec. 2, 2024 /PRNewswire/ — Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, along with ulrich GmbH & Co. KG, a renowned German medical device manufacturer specializing in contrast media injectors and spinal implants, announced today the clearance of the Bracco branded Max 3™, a Rapid Exchange and Syringeless Injector for use in magnetic resonance imaging (MRI) procedures.
PLEASANTON, Calif., Dec. 2, 2024 /PRNewswire/ — Movano Health (Nasdaq: MOVE), a pioneer in health technology, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the pulse oximeter in its EvieMED Ring.