Empyrean Medical Systems Submits its Bespoke Vektra™ Beam Sculpting Radiation Therapy System to FDA

Empyrean Medical Systems Submits its Bespoke Vektra™ Beam Sculpting Radiation Therapy System to FDA

PR Newswire

BOCA RATON, Fla., Oct. 19, 2026

FDA filing advances clinical entry for beam-sculpting brachytherapy and IORT

BOCA RATON, Fla., Oct. 19, 2026 /PRNewswire/ -- Empyrean Medical Systems, Inc. today announced the submission of 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. The submission completes a planned milestone in Empyrean's entry into clinical radiation oncology.

Vektra™ is the world's first robotically assisted rapid beam-sculpting X-ray photon platform for brachytherapy and IORT. It delivers conformal doses to target malignant tumors while minimizing dose to healthy tissue and organs at risk (OARs). This state-of-the-art treatment platform provides clinicians new options for invasive and minimally invasive cancer treatments.

Brachytherapy and IORT treat approximately 15% of patients receiving radiation oncology care (source: IAEA). Vektra™ brings disruptive precision, speed, and flexibility to this established clinical market.

"We're excited to bring Vektra™ to market and make a difference for cancer patients worldwide," said Pavlina Frolik, Vice President of Sales and Marketing. "We look forward to working with the world's leading radiation oncology centers to build clinical adoption, blaze new trails in treatment, and turn this state-of-the-art innovation into tangible clinical outcomes for patients and clinicians."

"I'm grateful to our hardware and software R&D, our Quality and Regulatory, and Scientific teams, and our industry partners for getting Vektra™ to its FDA submission milestone," said Johnathan Vainer, Chief Technology Officer. "Vektra™ builds on Sculptura™, our predecessor platform cleared in 2019. Feedback from our partner luminary centers of excellence shaped its performance and feature upgrades, including automated source placement and higher treatment energy. Those upgrades offer a robust, precise, and rapid system in clinicians' hands, with beam sculpting that provides clinicians greater treatment flexibility and safety."

Empyrean's next phase is clinical deployment and commercial scale-up following FDA clearance.

About Empyrean Medical Systems
Empyrean Medical Systems develops and commercializes radiation oncology technologies based on its proprietary X-ray photon beam sculpting and Magnetically Optimized Very High Energy Electron Therapy (MOVHEET), an approach developed by researchers at MD Anderson Cancer Center. It applies its patented technologies to improve treatment precision, safety, facility operational economics, and outcomes while reducing side effects. Empyrean's mission is to change how cancer patients are treated worldwide. Visit www.empyreanmed.com.

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SOURCE Empyrean Medical Systems, Inc.