Category: FDA

The AGENT DCB is available in Europe, parts of Asia Pacific and Latin America for the treatment of patients with ISR and previously untreated small vessel coronary disease. Boston Scientific plans to launch the technology in the U.S. in the coming months.

Tabrecta is the first FDA-approved therapy to treat non small cell lung cancer with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping).

The Cor® TRICUSPID ECM® valve has been successfully implanted in the 11th patient enrolled in the expansion by Dr. Marc Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Heart Center in Indianapolis, Indiana & principal investigator for the adult component of the study.

The Zeta Surgical Cranial Navigation System is a mixed-reality navigation system for neurosurgery, providing surgeons with "GPS-like" guidance with millimetric accuracy in real-time. Zeta's computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement, and allowing for awake and non-immobilized use in both operative and extra-operative settings.

Gabriel Sanchez, Ph.D., CEO and co-founder of Enspectra Health. "This significant achievement is the result of the excellent work by the Enspectra Health team and our clinical advisors. Our submission was cleared by the FDA ahead of plan, underscoring our ability to successfully drive an innovative technology from concept to clearance."