The FDA granted another indication for Sensus Healthcare’s topical skin cancer device, for treating keloid scars.
The Danbury, Conn.-based medical device company said its SRT-100 "superficial radiotherapy" product has already won 510(k) clearance from the federal watchdog for treating some skin cancers.
Sensus touts the device’s SharpBeam technology as targeting only lesion areas to spare adjacent healthy tissue. The SRT-100 is cleared for treating non-melanoma skin cancers such as basal cell and squamous cell carcinomas.
"It is very fortunate that the FDA has approved the Sensus SRT-100, the first computerized, state of the art in office SRT device, for the treatment of recurrent keloid scars. Dermatologists now have a safe, effective in office modality available to offer our keloid patients," said Mark Nestor, a doctor with the Center for Cosmetic Enhancement, said in a company statement.
Sensus acquired the SRT system in 2010 when Topex sold off its entire skin cancer treatment business. The SRT-100 is approved for non-melanoma cancer treatment in the U.S., U.K., Canada and Europe.
