FDA Approves OncoSil Device for Targeted Bile Duct Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted approval for OncoSil Medical's OncoSil device, a targeted radiation treatment for patients with unresectable, non-metastatic distal cholangiocarcinoma, a rare and aggressive bile duct cancer. This approval, under the FDA's Humanitarian Device Exemption framework, marks a significant regulatory milestone, allowing the Australian medical-device company to commercialize the device in the United States. The OncoSil device is the first and only FDA-approved Class III device for this specific indication, to be used alongside systemic therapy in adults over 21. A post-approval study is required, initially limiting its use to a maximum of five treatment centers.