MY01’s Pressure Monitor Designated FDA Breakthrough Device

Montreal, Canada-based MY01’s orthopedic Continuous Compartmental Pressure Monitor has received the FDA’s breakthrough device designation.

The device, which received the FDA’s 510(k) clearance earlier this year, provides real-time continuous pressure measurements to aid in the diagnosis of compartment syndrome, a painful condition caused by pressure buildup from internal bleeding or swelling of tissues.

The device is intended to help with early decision-making in acute compartment syndrome, reducing a patient's chance of amputation, infection, and nerve damage, as well as minimizing the need for surgery to relieve swelling and pressure.