Just a thought that FDA now may see the device review managers and pertinent personnel announced by DOGE were prematurely or similarly an error occurred in their early termination(s). No doubt we have observed and apprised that DOGE has succeeded in first identifying waste and fraud but inefficiencies within FDA. SOOOOO lets then see the door is still open for the reviewer who was originally charged with the UEEC PMA possibly called back to arms so to speak! Anything is possible but certainly a reason for the FDA statement to the company the IDE is still under review?
HMMMM!!!!
$5-$10+