FDA Grants 510(k) Clearance to Superficial Radiation Therapy for Skin Cancers and Keloids
Posted: Monday, August 13, 2018
The U.S. Food and Drug Administration (FDA) recently granted 510(k) clearance to Sensus Healthcare, Inc., to market its next-generation superficial radiation therapy—SRT-100+—for the treatment of non-melanoma skin cancers as well as keloids. SRT-100+ offers the same features as SRT-100, with the following additions: expanded energy range for customized, more precise treatment; remote diagnostics, including operation tracking; new x-ray tube with extended functionality and performance; and an advanced console and enhanced system mobility to optimize clinical practice.