Regulatory milestone supports China’s reproductive health goals by enabling radiation-free, high-accuracy ultrasound imaging to assess fallopian tube patency and uterine abnormalities in women.
BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys
TransMedics (Nasdaq:TMDX) announced today that the FDA says it can proceed with the initiation of a trial for its OCS Heart System.
Modular Medical (Nasdaq:MODD) announced today that it validated its insulin pump cartridge line for human-use production in the U.S.
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.