FDA Approves OncoSil™ Device for Distal Cholangiocarcinoma

A new treatment option is now available for some patients with distal cholangiocarcinoma (dCCA) in the United States.

On August 17, 2026, OncoSil Medical announced that the U.S. Food and Drug Administration (FDA) granted Humanitarian Device Exemption (HDE) approval to the OncoSil™ device for adults with unresectable, non-metastatic distal cholangiocarcinoma, including patients with locally advanced disease or those who are not candidates for surgery.

OncoSil is a single-use brachytherapy device that delivers targeted radiation directly into a tumor. Using endoscopic ultrasound guidance, phosphorus-32 (32P) microparticles are implanted within the tumor, providing localized radiation while aiming to limit exposure to surrounding organs. The device is intended to be used alongside systemic therapy.

What Does HDE Approval Mean?

The FDA’s Humanitarian Device Exemption pathway is designed for medical devices intended to treat rare diseases or conditions. Unlike traditional FDA approval pathways, HDE approval does not require the same demonstration of reasonable assurance of effectiveness. Instead, the FDA determines that the device does not pose an unreasonable or significant risk and that its probable benefits outweigh its risks.

The approval is an important development for a population with limited treatment options. Distal cholangiocarcinoma is an aggressive cancer, and many patients are unable to undergo surgery with curative intent.

As a condition of approval, OncoSil’s initial U.S. use will be limited to up to five treatment centers with appropriately trained physicians. An FDA-required post-approval study is also expected to enroll 30 patients and further evaluate the device’s safety and probable benefit.

“Distal cholangiocarcinoma is a rare and aggressive cancer with a significant need for new therapeutic approaches,” said Juan Valle, Chief Medical Officer of the Cholangiocarcinoma Foundation. “The FDA’s HDE approval of this device is an important development, providing eligible U.S. patients and clinicians with an additional treatment option through targeted radiation delivered directly within the tumour.”

As OncoSil becomes available at specialized U.S. centers, continued study will help the medical community better understand its role in the multidisciplinary treatment of eligible patients with distal cholangiocarcinoma. We encourage eligible patients to speak with their providers about this new therapeutic approach.