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FDA Grants 510(k) Clearance to SRT-100+ Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and Keloids

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Sensus Healthcare, Inc, a medical device company specializing in the noninvasive treatment of nonmelanoma skin cancers and keloids with image-guided superficial radiation therapy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new SRT-100+, a superficial radiation therapy solution that adds several 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 nonmelanoma skin cancers 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 content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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