The U.S. FDA awarded a humanitarian device exemption (HDE) approval to Oncosil Medical’s Oncosil brachytherapy device for distal cholangiocarcinoma, according to the company’s disclosure. Oncosil said it becomes the first and only U.S. FDA-approved Class III device for this rare bile duct cancer indication. HDE pathways are designed for conditions affecting small patient populations, typically providing limited commercial use while still requiring safety and performance evidence. The approval gives clinicians an additional procedural option for dCCA. For Oncosil, the clearance represents a regulatory milestone that may accelerate adoption and investment as the company supports further evidence generation in an area with few targeted options.