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 achievement places MY01 among ju
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.
Notably, the FDA granted full clearance without any additional questions or qualitative requests. This highlights the commitment of the MY01 team and the reliability of MY01’s technology and regulatory strategy.
“This accomplishment demonstrates the unwavering dedication of our team,” said Olivier Bataille, Chief Operating Officer at MY01. “Over the past 10 months, they prioritized MY01’s mission to meet our NTAP deadline. Their perseverance and commitment have enhanced our ability to provide healthcare professionals with the tools needed to optimize patient outcomes.”
With this FDA clearance, MY01 is authorized to market the perfusion pressure feature, making it commercially available in the United States. Clinicians will now be able to monitor not only compartment pressure (CP) but also input diastolic blood pressure (DBP) to calculate perfusion pressure (ΔP), allowing for a more comprehensive assessment of the patient’s condition.
About MY01, Inc
Founded in 2019 and based in Montreal, MY01 envisions a world where every disease is quantifiable, enabling precise, personalized care for all patients. At MY01, our advanced sensor technology platform has the ability to transform trauma programs by translating complex biological signs into dynamic, actionable, real-time data to inform better decision-making, thereby reducing variation in care and delivering better outcomes, allowing hospitals to allocate resources as efficiently as possible. With our CPST Platform, clinicians are able to visualize objective, continuous disease progression, empowering the healthcare facility to match the needs of the injured to the appropriate levels of care. MY01 is commercial in the USA, Europe, and Canada, setting new standards in healthcare.