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.
Vektra builds on Sculptura, cleared in 2019, with automated source placement and higher energy
Chief Technology Officer Johnathan Vainer said Vektra extends Sculptura, the predecessor platform cleared in 2019. Feedback from partner centers of excellence shaped the upgrades, which include automated source placement and higher treatment energy. Vainer said beam sculpting gives clinicians greater treatment flexibility and safety.
Commercial scale-up depends on FDA clearance
Vice President of Sales and Marketing Pavlina Frolik said Empyrean plans to work with leading radiation oncology centers to build clinical adoption. The company's next phase is clinical deployment and commercial scale-up following FDA clearance. No clearance timeline was disclosed.