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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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.
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.
The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.