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Latest From Transmedics, Inc.
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.
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week’s approvals include the US FDA's approval of a panel-track supplement for TransMedics' OCS Lung system to preserve donor lungs that would not be salvageable using a traditional cold static 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.
Paragonix Technologies, which developed the first CE-marked and US FDA-cleared medical device system for transporting donor hearts, is ramping-up marketing in Europe and the US while continuing to expand its technology platform to kidney and lung transplants.
- Medical Devices