Health Check: Oncosil scores rare FDA win with bile duct cancer

Oncosil Medical secured FDA approval for its bile duct cancer treatment device under the Humanitarian Device Exemption pathway, marking it as the first approved Class III device for distal cholangiocarcinoma. This approval opens a US market opportunity estimated at $80 million for treatment of inoperable, non-metastatic patients with limited survival options.

This Wire brief sits within Fusion42's coverage of Medtech, and 4 sources have reported it between 17 Aug 2026 and 18 Aug 2026.