FDA accepts BiVacor Total Artificial Heart into TAP advisory program
August 6, 2025
BiVacor announced today that the FDA accepted its Total Artificial Heart (TAH) into its Total Product LifeCycle Advisory Program (TAP).
BiVacor announced today that the FDA accepted its Total Artificial Heart (TAH) into its Total Product LifeCycle Advisory Program (TAP).
AbbVie has announced that it has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for ELAHERE (mirvetuximab soravtansine) as monotherapy for the treatment of eligible adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
The RS001 chest-worn device directly measures respiration and provides passive cardio-respiratory monitoring.
Regulatory green light marks full commercial launch of LungVision, enhancing early lung cancer detection through AI-driven 3D imaging for more precise bronchoscopic diagnostics.
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.