Elekta receives FDA 510(k) clearance for Versa HD Radiation Therapy System for cancer treatment


Elekta recently received 510(k) clearance from the US Food and Drug Administration (FDA) which allows the company to begin shipping and installation of all components of the Versa HD system within the USA, according to a release. High precision beam shaping and tumour targeting and radiation dose delivery are 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. Further, the operational benefits for clinicians and providers are eagerly anticipated.”

Fully integrated with the Agility 160-leaf multileaf collimator, Versa HD provides high-definition, high-speed beam shaping over a versatile 40×40 cm field. This unique combination of fast multileaf collimator leaf speed with the new high dose rate mode empowers clinicians to fully exploit high dose rate delivery and take advanced therapies such as VMAT, SRS and SRT to new levels—without compromising treatment times, according to the company.

Versa HD also features:

  • Safety innovations
  • Customisable, disease-specific configurations
  • Modern patient-friendly ergonomics
  • Fewer delays and downtime with real-time remote system monitoring
  • Low environmental impact, low energy consumption design

Versa HD is not available for sale or distribution in all regions.