25 January 2021 - Novel perfusion monitor achieves FDA breakthrough device Designation for real-time, peri-procedural monitoring of tissue perfusion in patients with critical limb threatening ischaemia.
PEDRA Technology announced today that the U.S FDA has granted the company a breakthrough device designation for the peri-procedural use of its PEDRA Xauron Perfusion System in the treatment of critical limb threatening ischaemia.