OncoPatch announced that it received FDA 510(k) for its Oncopatch Surface brachytherapy system for treating localized tumors.
The technology offers a distinct, patch-based approach to delivering beta radiation directly to skin cancers and superficial lesions. It enables precise surface treatment while minimizing exposure to underlying healthy tissue.
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Colorado-based OncoPatch designed its system to deliver targeted radiation therapy to superficial lesions in dermatology settings with appropriate, authorized user oversight. It may be used as a primary treatment or for residual disease following excision of primary or recurrent skin tumors.
OncoPatch says its device can deliver therapy in a short course of just 1-5 sessions. The company aims to expand treatment options while supporting patient convenience and cosmetic outcomes.
Dr. Patricia Walker, a board-certified dermatologist, said in a news release that the non-invasive, surface brachytherapy system can give clinicians additional flexibility, “particularly in situations where tissue preservation and patient experience are important considerations.”
OncoPatch received FDA clearance in December 2025 and plans to kick off a controlled, limited launch in Colorado this year. It then plans for a broader U.S. expansion in 2027.
David Westerly, co-founder and CEO of OncoPatch, said:
“Oncopatch was developed by physicists and radiation oncology researchers with the explicit goal of bringing a precise, isotope-based radiation therapy option into dermatology practice. This FDA clearance reflects years of work in radiation physics, clinical care, and collaboration across academic institutions. Our focus now is on a disciplined rollout that ensures this technology is implemented thoughtfully and delivers meaningful value for patients with skin cancer.”
