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 US FDA released updated safety information on Endologix Inc.’s AFX2 Endovascular abdominal aortic aneurysm (AAA) graft system on Tuesday. Previous devices in the product line have been associated with an increased risk of abnormal bleeding.