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Health Check: Oncosil scores rare FDA win with bile duct cancer
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Fusion42 · 17 August 2026 · Fusion42 review
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.
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◆ ◆ The Wire takeaway
You have a rare chance to serve a tiny but urgent US market for bile duct cancer with FDA backing. Lock in early collaborations to establish treatment sites as only five centres can offer this device initially.
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