FDA Clears Xstrahl’s Radiant Aura for NMSCs

Radiant Aura is an office-based radiation therapy for non-melanoma skin cancers.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Xstrahl’s Radiant Aura, an office-based radiation therapy for non-melanoma skin cancer (NMSC).

“We developed Radiant Aura to deliver both electronic brachytherapy and superficial radiation therapy in order to give dermatologists multiple treatment options for their NMSC patients,” says Adrian Treverton, CEO of Xstrahl, in a news release. “Low-dose, X-ray based therapy gives dermatology practices a non-invasive treatment option for patients when surgery is not possible, contraindicated, or simply not preferred due to cosmetic concerns. Radiant Aura is the new generation of Radiant systems and has had multiple upgrades based on our early users’ experience and recommendations.”

Radiant Aura offers an extended range of motion, one-handed manipulation, and easy maneuverability due to a re-engineered treatment arm, including a new telescopic treatment head. Patient set-up involves a simple applicator and filter insertion and removal process, and electromagnetic brakes lock movement for greater patient safety. New 2.5cm, 5cm, and 8cm applicators are also available.

Dermatologist and Mohs surgeon Dr. John Q. Binhlam, from Advanced Skin & Laser Center in the Nashville, TN area, took part in the evaluation of the new system. “The first patient I treated using Radiant was not a good candidate for surgery because he was an elderly gentleman who had multiple squamous cell carcinomas of the nose, forehead, and cheek that would have been deforming had surgical removal been performed for all of the lesions,” he says. “His radiation therapy treatment occurred in short 10-15 minute sessions and the skin cancers responded very favorably.”

Radiant Aura is available for immediate delivery.