TransMedics Announces Approval Of Heart Transplant Device
The OCS Heart System is expected to expand the number of hearts available for transplant.
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OCS Liver System Moves One Step Closer To Approval After Panel Recommendation
A panel of medical experts recommended that the US Food and Drug Administration grant premarket approval to a system designed to preserve and monitor livers destined for transplant recipients.
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.