SurgiBox, a medical technology company committed to improving access to safe, clean surgery at the point of need, announced today it has received the CE Mark under MDR for the medical devices that comprise its flagship product, the SurgiField System.

BEDFORD, Mass., Aug. 7, 2025 /PRNewswire/ — Instylla, Inc., a privately held company developing novel resorbable embolics for peripheral vascular embolization, announced premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the company’s flagship product Embrace™ Hydrogel Embolic System. Embrace HES has been approved for the embolization of hypervascular tumors in peripheral arteries ≤ 5mm.

BiVacor announced today that the FDA accepted its Total Artificial Heart (TAH) into its Total Product LifeCycle Advisory Program (TAP).

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.

BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys