TransMedics Heart Transplant Tool Lands FDA Panel Date After 6-Month Delay
Executive Summary
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...
TransMedics Faces 2nd Panel Date Postponement
The company said the postponement will give the US FDA additional time to review trial data.
TransMedics Earns Second PMA For OCS Lung 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.
Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217
The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.