Empyrean Files 510(k) for Vektra Robotic Brachytherapy System
Boca Raton – October 19, 2026 -- Empyrean Medical Systems has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for Vektra, its robotically assisted brachytherapy and intraoperative radiation therapy (IORT) system, completing a planned milestone in the company's move into clinical radiation oncology.
Vektra targets a segment treating about 15% of radiation oncology patients
Empyrean describes Vektra as the world's first robotically assisted, rapid beam-sculpting X-ray photon platform for brachytherapy and IORT. The system is designed to deliver conformal doses to malignant tumors while limiting dose to healthy tissue and organs at risk. Brachytherapy and IORT together treat approximately 15% of patients receiving radiation oncology care, according to the International Atomic Energy Agency (IAEA) figure cited by the company.