https://medtechspectrum.com/news/40/24634/mirus-secures-ntap-approval-from-cms-for-breakthrough-europa-cervical-spine-system.html
SHENZHEN, China, Aug. 4, 2025 /PRNewswire/ — Pulsecare Medical, a pioneer in cardiovascular intervention technologies, announced that its innovative NxPFA™ nanosecond pulsed field ablation (ns-PFA) systemhas received marketing approval from China’s National Medical Products Administration (NMPA). As the world’s first third-generation ns-PFA system utilizing high-voltage nanosecond pulses for pulmonary vein isolation (PVI) in atrial fibrillation (AF) treatment, this breakthrough marks the dawn of the PFA 3.0 era and represents the innovative capabilities of Pulsecare Medical in cardiovascular multimodal therapy.
Stereotaxis (NYSE:STXS) announced today that it received FDA 510(k) clearance for its Magic Sweep navigation catheter.
Getinge announced today that European regulatory authorities reinstated the CE mark for its Cardiosave intra-aortic balloon pump.
Carlsmed (Nasdaq:CARL) today announced new technology add-on payment (NTAP) reimbursement for its spine implant technology.
MIT spinout Tissium recently secured FDA marketing authorization of a biopolymer platform for nerve repair.
EvoEndo announced today that it received expanded FDA clearance for its Model LE gastroscope, covering patients of all ages.
SetPoint Medical announced today that the FDA approved its SetPoint neuroimmune modulation system for treating rheumatoid arthritis (RA).
AUSTIN, Texas, July 30, 2025 /PRNewswire/ — Alafair Biosciences, a medical device company redefining soft-tissue protection in orthopedic surgery, announced today that it has received two 510(k) clearances from the FDA for VersaCoat™ Tendon Protector and VersaCoat™ Nerve Protector, marketed as a single product, VersaCoat™ Flowable Hydrogel.
Bioventus (Nasdaq:BVS) announced today that it received FDA 510(k) clearance for both its TalisMann and StimTrial offerings.