Medical devices maker Sensus Healthcare has secured 510(k) clearance from the US Food and Drug Administration (FDA) to commercialize its new SRT-100+ superficial radiation therapy solution to treat non-melanoma skin cancer and keloids.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
The SRT-100+ superficial radiation therapy solution provides advanced features for patients and doctors, including remote diagnostics and patient medical records integration, as well as core system enhancements.
Sensus Healthcare chief technology officer Kal Fishman said: “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.”
Similar to the SRT-100, the SRT-100+ radiation therapy solution offers an expanded energy range for customized and more precise treatment.
The SRT-100+ radiation therapy solution also features new X-ray tube with extended functionality and performance, as well as an advanced console and enhanced system mobility to optimize clinical practice.
In addition, the SRT-100+ solution can be used in remote diagnostics applications, including operation tracking.
Sensus Healthcare CEO Joe Sardano said: “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.”
Sensus Healthcare is involved in the development of providing non-invasive and cost-effective treatments for non-melanoma skin cancers and keloids.
The company uses advanced low-energy X-ray technology under the name of superficial radiation therapy (SRT).
Sensus has integrated SRT into its portfolio of treatment devices, including SRT-100, SRT-100+ and SRT-100 Vision.
The SRT-100 is a gentle basal cell carcinoma (BCC) treatment that only penetrates five millimeters below the skin’s surface. It can destroy cancer cells without cutting, bleeding, stitching or scarring.
The SRT-100, which can be used to remove basal cell carcinoma anywhere on the body, works better on BCC located on the face, lower lip, rim of the ear, balding scalp, neck, hands, arms and legs.
SRT technology is currently used for the treatment of patients with oncological and non-oncological skin conditions.
The company also provides Sensus laser systems, which are three next-generation devices for the aesthetic dermatology market.