Elekta Receives FDA 510(k) Clearance Following Launch of New Versa HD Radiation Therapy System 


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Elekta recently received 510(k) clearance from the FDA, allowing the company to begin shipping and installation of all components of the Versa HD system within the United States. The Versa HD radiation system, featuring high-precision beam shaping and tumor targeting, is capable of delivering radiation doses three times faster than previous Elekta linear accelerators.

“We are delighted to receive FDA clearance,” says Jay Hoey, Executive Vice President, Elekta North America. “The potential clinical benefits for patients are significant.”

High Dose Rate Delivery

Versa HD is fully integrated with the Agility 160-leaf multileaf collimator and provides high-definition, high-speed beam shaping over a versatile 40×40 cm field. The unique combination of fast multileaf collimator leaf speed with the new High Dose Rate mode allows clinicians to fully exploit high dose rate delivery and take advanced therapies such as volumetric modulated arc therapy, stereotactic radiosurgery, and stereotactic radiotherapy to new levels, without compromising treatment times.

Versa HD also features advanced safety features; customizable, disease-specific configurations; real-time remote system monitoring; and patient-friendly ergonomics. ■



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