Philips (NYSE:PHG) announced today that the FDA granted 510(k) clearance for its new detector-based spectral computed tomography (CT) radiotherapy solution.
TEL AVIV, Israel and FORT LAUDERDALE, Fla., Nov. 11, 2024 /PRNewswire/ — Momentis Surgical Ltd., a leader in robotic-assisted surgical innovation, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its second-generation Anovo® robotic surgical platform.
IRVINE, Calif., Nov. 7, 2024 /PRNewswire/ — Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced the U.S. Food & Drug Administration (FDA) approval of the VARIPULSE™ Platform for the treatment of drug refractory paroxysmal Atrial Fibrillation (AFib).
Corin announced that it received FDA 510(k) clearance for its Icona femoral stem implant for total hip arthroplasty (THA).
BOSTON, Nov. 6, 2024 /PRNewswire/ — Zeta Surgical announced today that its Zeta Navigation System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with expanded instruments and enhanced hospital connectivity.
SimBioSys announced that it received its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons in the U.S.
Akura Medical, a Shifamed portfolio company, announced today that the FDA granted its Katana system investigational device exemption (IDE).
NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve stimulator.
LAS VEGAS, Nov. 4, 2024 /PRNewswire/ — SeeMedX Inc. (“SeeMedX”) today announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its innovative, non-invasive cardiac monitoring device, designed to allow medical professionals to have real-time insights into cardiac performance and fluid status
Quanta Dialysis Technologies announced today that it received FDA 510(k) clearance for the use of its dialysis system in the home.