Posted by Michael Wonder on 20 Jul 2023
T2 Biosystems receives FDA breakthrough device designation for Candida auris diagnostic test
20 July 2023 - T2 Biosystems announced today the US FDA has granted breakthrough device designation for the Company’s Candida auris direct from blood molecular diagnostic test.
This marks the third T2 Biosystems’ product to receive FDA breakthrough device designation, as the Company was previously granted FDA breakthrough device designation for its T2Resistance Panel and T2Lyme Panel.
