The FDA awarded a humanitarian device exemption (HDE) approval to Oncosil Medical’s Oncosil brachytherapy device for distal cholangiocarcinoma. The decision makes Oncosil the first and only U.S. FDA-approved Class III device for this rare bile duct cancer indication, according to CEO Nigel Lange. Brachytherapy provides localized radiation delivery through implanted sources, and HDE status is intended for conditions affecting small patient populations where conventional approval pathways may be challenging. The HDE clearance supports Oncosil’s positioning for treatment programs in specialized oncology centers. The device approval also adds to the growing list of interventional oncology tools seeking to address hard-to-treat gastrointestinal malignancies. Hospitals and clinicians will now evaluate logistics, patient selection, and integration into existing care pathways. For investors and developers, the HDE outcome highlights how niche device programs can still progress to FDA clearance when clinical need and feasibility align.