OncoSil progresses HDE with US FDA
Filed with ASX · · 3 pages · English
Summary by 6ix AI
OncoSil Medical Ltd has announced that its Humanitarian Device Exemption application has reached the final review stage with the U.S. FDA, confirming that all outstanding questions have been satisfactorily addressed. The FDA has requested final device labeling and any updates to the proposed post-market study, with an intention to complete its review within a specified timeframe. This marks a significant regulatory milestone for OncoSil, as it is the last step before potential approval for the OncoSil™ device for treating distal cholangiocarcinoma in the U.S.
Written by 6ix AI from the company’s filing. How 6ix writes summaries
In the deck
Earlier from OncoSil Medical
- OncoSil Medical Receives TGA Approval in Australia
- Security Class Reinstatement to Quotation - OSLOE
- Security Class Suspension from Quotation
- Appendix 4D and Half Year Accounts
- CEO Remuneration Update
Later from OncoSil Medical
- OncoSil Selected for Major European Pancreatic Cancer Study
- OncoSil Medical Files for FDA Approval
- OncoSil Medical Completes Manufacturing Validation
- OncoSil Receives FDA Approval for Distal Cholangiocarcinoma
- OSL Secures $5.6 million from Major Institutional Investors
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