Neurovalens receives EU MDR compliance for sleep insomnia device
March 26, 2026
Achieving MDR compliance shows Modius Sleep meets safety, clinical, and quality standards required for entry into the EU market.
Achieving MDR compliance shows Modius Sleep meets safety, clinical, and quality standards required for entry into the EU market.
BEIJING, March 26, 2026 /PRNewswire/ — Wingderm®, a manufacturer of medical aesthetic devices, announces that its Lasermach system has received expanded clearance from the U.S. Food and Drug Administration (FDA). With this latest clearance, Lasermach now achieves FDA clearance across all three wavelengths.
Inspire Medical (NYSE:INSP) announced today that it received expanded FDA approval for its Inspire IV and V neuromodulation systems.
Pixee Medical announced today that it received CE mark approval for Knee+ NexSight, with the first cases already performed in Europe.
DOVER, Del., March 24, 2026 /PRNewswire/ — Orca Dental AI, the global leader in AI-powered orthodontic imaging solutions and creator of the CephX platform, today announced it has received FDA clearance for 3D imaging, marking a major milestone in the company’s mission to bring advanced AI-powered diagnostic support into everyday clinical workflows.
MOUNTAIN LAKES, N.J., March 24, 2026 /PRNewswire/ — LiviWell, a women’s health company dedicated to developing innovative solutions for intimate health, today announced that the U.S. Food and Drug Administration (FDA) has cleared Livi, a first-of-its-kind device designed to support vaginal health by absorbing semen and other post-intercourse fluids.
GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its Photonova Spectra solution.
Growing evidence has demonstrated that low-dose radiation can target inflammation and reduce pain for osteoarthritis patients.
LivaNova (Nasdaq: LIVN)+ announced today that it received FDA premarket approval (PMA) for its aura6000 neuromodulation system for sleep apnea.
JenaValve announced today that it received FDA premarket approval (PMA) for its Trilogy THV system.