FDA Clears Sensus Healthcare’s SRT-100+ Superficial Radiation Therapy

Sensus Healthcare Inc., a medical device company specializing in the non-invasive treatment of non-melanoma skin cancers (NMSC) and keloids with Image-Guided Superficial Radiation Therapy (IGSRT), today announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new SRT-100+, the next-generation Superficial Radiation Therapy solution that adds several innovative features to Sensus’ existing SRT-100 product.
 
“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,” said Kal Fishman, chief technology officer, Sensus Healthcare. “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 (EMR), 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.”
 
The SRT-100+ offers all of the same features of the SRT-100, with:
 

• An expanded energy range for customized, more precise treatment
• Remote diagnostics, including operation tracking
• New X-ray tube with extended functionality and performance
• Advanced console and enhanced system mobility to optimize clinical practice

 
“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,” added Joe Sardano, CEO, Sensus Healthcare. “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.”
 
The SRT-100+ is available for sale immediately.