SAN MATEO, Calif., Nov. 13, 2024 /PRNewswire/ — SonoMotion, a medical device company developing non-invasive solutions for kidney stones, announced today that the FDA has granted de novo clearance for the Company’s Stone Clear™ device for the anesthesia-free treatment of post-lithotripsy kidney stone fragments.
LAUSANNE, Switzerland, Nov. 13, 2024 /PRNewswire/ — SmartCardia has received FDA clearance for Mobile Outpatient Cardiac Telemetry (OCT/MCT) for its 7-lead live ECG monitoring patch and cloud platform. SmartCardia’s 7L patch is easy-to-wear, cable-free, waterproof and can be used for continuous monitoring for up to 14 days
Johnson & Johnson MedTech announced today that the FDA granted its Ottava surgical robot investigational device exemption (IDE).
Magstim announced today that the FDA cleared its next-generation Horizon Inspire system for delivering transcranial magnetic stimulation (TMS).
iCad (Nasdaq:ICAD) announced today that the FDA cleared its ProFound Detection version 4.0 for digital breast tomosynthesis (DBT).
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.