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FDA Reviewers Raise Concerns About Value Of TransMedic’s OCS Liver System Trial Data

As experts convene to discuss whether to recommend approval of the device, agency reviewers are concerned about what the primary endpoint and organ selection criteria used in trials mean for safety and efficacy.

TransMedics' OCS Liver System
• Source: TransMedics

The US Food and Drug Administration has raised some concerns about clinical trial data of TransMedics’ Organ Care System (OCS) Liver System as experts are scheduled to deliberate during a public panel meeting.

The FDA’s gastroenterology and urology devices advisory committee is set to convene a meeting on 14 July to discuss whether...

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