TransMedics Liver Transplant Device Gets July Panel Date
The US FDA panel will look at a PMA for the TransMedics OCS Liver System, which helps keep donor livers stable and healthy as they await transplant.
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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 Earns Second PMA For OCS Lung System
FDA approved a PMA supplement to allow TransMedics' Organ Care System (OCS) to be used for the preservation and ex-vivo assessment of lungs that would not be acceptable for transplant if they had been preserved with a standard cold static system.
EPA Gives Stakeholders Additional 15 Days For EtO Comments
The deadline for comments on the Environmental Protection Agency proposal, which trade groups say could lead to device shortages if implemented, has been moved from 12 June to 27 June.