The FDA granted humanitarian device exemption (HDE) approval to Oncosil Medical Ltd.’s Oncosil brachytherapy device for distal cholangiocarcinoma. Oncosil is positioned as the first and only U.S. FDA-approved Class III device specifically for the rare bile duct cancer. For clinicians, the HDE pathway signals an effort to bring device-based therapy options into a space where treatment decisions can be constrained by rarity and evidence generation challenges. The approval also highlights ongoing expansion of interventional oncology toolkits through device regulatory designations. The company said the approval was shared during a conference call with analysts, with CEO Nigel Lange emphasizing the device’s unique status in the U.S. market.