The FDA granted humanitarian device exemption (HDE) approval to Oncosil Medical’s Oncosil brachytherapy device for distal cholangiocarcinoma. The approval makes Oncosil the first and only US FDA-approved Class III device for dCCA under HDE. Oncosil is intended to expand procedural options for a rare bile duct cancer where treatment decisions can be constrained by patient selection and disease anatomy. CEO Nigel Lange said the decision came via a conference call with analysts. While HDE programs are limited to specified patient populations, the approval creates a new benchmark for future device development in cholangiocarcinoma and may drive adoption planning in specialty centers.