Superficial radiation therapy device developer Sensus Healthcare (NSDQ:SRTSU) said today it won FDA 510(k) clearance for its SRT-100+ next-gen superficial radiation therapy system.
The newly cleared device includes all the features of the Boca Raton, Fla.-based company’s SRT-100 as well as an expanded energy range, remote diagnostics and operation tracking, a new X-ray tube for extended functionality and an advacned console and system mobility.
“We have integrated both clinical and patient feedback to bring to life exciting new elements with the SRT-100+—from live lesion and patient cameras for monitoring during treatment to best-in-class system enhancements for better patient setup and comfort. The sophisticated operation of the SRT-100+ also offers significant benefits to doctors specifically, as it will be integrated with practices’ information technology and management / electronic medical records, as well as provide vital data backup and logging. This represents the technology of the future when it comes to treating NMSC and keloids safely and effectively,” CTO Kal Fishman said in a prepared statement.
“The SRT-100+ is truly the next step forward for Sensus’ transformative products that have treated more than 400,000 skin cancer and keloids patients all around the world. This new offering is the culmination of all of our clinical experience and best practices that we have learned from our broad global user base of physicians and patients. Most importantly, this 510(k) market clearance uniquely positions Sensus to fuel continued innovation in the clinical dermatology space,” CEO Joe Sardano said in a press release.
In April, Sensus Healthcare released plans for a global expansion, including new distribution agreements in China, Germany, Mexico, Cuba and Costa Rica.
