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OncoSil Medical Wins FDA Approval for Rare Bile Duct Cancer Device

8:35am on Monday 17th of August, 2026 AEST Healthcare
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OncoSil Medical Wins FDA Approval for Rare Bile Duct Cancer Device

8:35am on Monday 17th of August, 2026 AEST
Key Points
  • FDA grants HDE approval for OncoSil™ in distal cholangiocarcinoma
  • First and only Class III device approved for this rare bile duct cancer
  • US addressable market estimated at 1,000 patients and A$80 million
  • Initial use limited to five centres under post-approval study
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