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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

510(k) Filed

Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system

MedDevice Startups Staff · 2 days ago · 2 min read · Via MD+DI

Empyrean Medical Systems submitted a 510(k) to FDA for Vektra, a robotically assisted system for brachytherapy and intraoperative radiation therapy. The Boca Raton company announced the filing on October 19.

Vektra builds on Sculptura, which FDA cleared in February 2019 and which Empyrean bought from Sensus Healthcare for $15 million in cash in February 2022. That purchase covered Sculptura inventory and the related intellectual property. Vektra adds automated source placement and higher treatment energy, changes Empyrean credits to its partner centers.

Brachytherapy and intraoperative radiation therapy reach about 15 percent of patients who get radiation oncology care, a figure Empyrean attributes to the IAEA. The company named no predicate device and gave no review timeline. Buying a cleared platform and filing the upgrade as a 510(k) is the cheap way into radiation oncology hardware, where a De Novo would mean standing up a new regulation.

Questions & Answers

What did Empyrean Medical Systems submit to FDA in October 2026?

On October 19, 2026, Empyrean Medical Systems announced it had submitted a 510(k) premarket notification for Vektra, a robotically assisted brachytherapy and intraoperative radiation therapy system. FDA clearance is still pending.

How is Empyrean's Vektra related to Sculptura?

Vektra builds on Sculptura, a beam-sculpting radiation therapy platform FDA cleared in February 2019. Empyrean acquired the Sculptura assets and intellectual property from Sensus Healthcare for $15 million in cash in February 2022, and Vektra adds automated source placement and higher treatment energy.

Where is Empyrean Medical Systems based?

Empyrean Medical Systems is based in Boca Raton, Florida. It builds robotically assisted radiation therapy systems for brachytherapy and intraoperative radiation therapy.

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