FDA Grants 510(k) Clearance for Perfusion Pressure on the MY01’s Mobile Application
MONTREAL, QC – March 18, 2025 – MY01, an innovative medical technology company dedicated to transforming the diagnosis of limb perfusion injuries, is excited to announce that the inclusion of Perfusion Pressure, a key physiological indicator for complications like compartment syndrome or acute limb ischemia, on the MY01 Mobile Application, has received 510(k) marketing authorization from the FDA, along with Breakthrough Designation. This milestone advances the company’s mission to reduce trauma variability and improve patient outcomes through objective, data-driven insights. It also opens the door for inpatient reimbursement coverage through the New Technology Add-on Payment (NTAP) program.
