Pedra Tissue Perfusion System Receives FDA Breakthrough Device Designation
Pedra Tissue Perfusion System Receives FDA Breakthrough Device Designation Novel perfusion monitor allows real-time, periprocedural monitoring of tissue perfusion in patients with critical limb threatening ischemia The Pedra Blood Perfusion Index tracks real-time changes in foot tissue perfusion attendant with balloon inflation and deflation during an angioplasty procedure. January 26, 2021 — Pedra Technology, a privately held company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for the periprocedural use of its ...
Source: dicardiology.com