Radiology oncology vendor Elekta announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Harmony linear accelerator.
Company officials said the accelerator was designed with the expectation that hypofractionation-enabled systems capable of stereotactic body radiotherapy will become routine at suburban radiotherapy centers.
Harmony includes Elekta's FastTrack in-room experience that reduces patient setup time by as much as 50%, according to the firm. When combined with workflow enhancements, the time allocated to treatment slots can be reduced by up to 25%.
The linear accelerator also includes Eleketa's multileaf collimator, which provides 1-mm beam shaping across the full 40 x 40-cm field size, according to the company.
The Harmony accelerator also carries the European CE Mark. It is not yet available in all markets, the company said.
