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 Food and Drug Administration approved a panel-track PMA supplement for TransMedics Inc.’s Organ Care System (OCS) Lung, allowing it to be used for the preservation of donor lungs that would be unacceptable for transplantation with standard cold static preservation.
OCS Lung combines perfusion, ventilation and monitoring systems into a single portable device that can maintain donated lungs in a...
Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
