ShiraTronics initiates FDA IDE study for implantable neuromod
December 4, 2024
ShiraTronics announced that it initiated its FDA investigational device exemption (IDE) pivotal trial for its neuromodulation therapy.
ShiraTronics announced that it initiated its FDA investigational device exemption (IDE) pivotal trial for its neuromodulation therapy.
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.
MELVILLE, N.Y., Dec. 4, 2024 /PRNewswire/ — At October’s Inner Circle Invitational in Boca Raton, Cartessa Aesthetics introduced three new technologies to the nearly 400 aesthetic providers in attendance.
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.
FastWave Medical today announced the sixth U.S. utility patent for its laser-based intravascular lithotripsy (IVL) technology for treating calcific artery disease.
The new balloon can be expanded before a meal to prevent overeating, then deflated when no longer needed.
Nonin Medical has won FDA 510(k) clearance for its first over-the-counter fingertip pulse oximeter, the TruO2 OTC.