TransMedics Heart Transplant Tool Lands FDA Panel Date After 6-Month Delay
The US agency’s circulatory system devices panel will take up the company’s heart transplant tool in an October virtual session.
You may also be interested in...
The company said the postponement will give the US FDA additional time to review trial data.
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 government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.