Elekta’s Harmony Radiation Therapy Device Gets 510(k) Clearance

Elekta’s Elekta Harmony radiation therapy system has received 510(k) clearance from the FDA.

The Atlanta-based company’s radiotherapy device uses a technique called hypofractionation, a form of external radiation therapy that emits high-energy X-ray beams.

Recent clinical results have shown the technique to be effective against “a variety of malignancies, including prostate, breast and lung cancers,” according to John Christodouleas, Elekta’s senior vice president of medical affairs and clinical research.