W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration’s (FDA’s) premarket approval (PMA) of the Gore Cardioform ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs). The FDA approval was supported by data collected from the pivotal stage of the Gore ASSURED Clinical Study, which demonstrated 100 percent closure success at the six-month evaluation in patients with a successful implant.

Medivis announced that its augmented reality (AR) technology platform for surgical applications, SurgicalAR, has received 510(k) clearance for clinical use in the operating room by the U.S. Food and Drug Administration (FDA). The New York City-based medical technology company will commence the immediate commercialization of the platform in the United States.