MY01 Inc. receives their first-ever “Breakthrough Device” designation by the FDA in October, joining a select list of Orthopaedic companies to receive this designation since the program began in 2016.
The Breakthrough Device Designation is an FDA designation granted to devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Since the inception of the Breakthrough Devices Program in 2016, orthopaedics has accounted for only 6% of devices that have received this designation, making it an underrepresented group of technologies that have the potential to improve patient care.
The MY01 Continuous Compartmental Pressure Monitor provides reliable1, real-time continuous pressure measurements to aid in the diagnosis of compartment syndrome. The receipt of Breakthrough Device Designation demonstrates that MY01 can offer significant advantages over existing alternatives for more effective and efficient management of Compartment Syndrome (CS).
While clinical assessment alone or single-point measurements can lead to delayed diagnosis or overtreatment, continuous IntraCompartmental Pressure (cICP) augments early decision-making in Acute Compartment Syndrome (ACS). Optimal management of ACS depends on early diagnosis and intervention, which significantly reduces a patient’s chance of amputation, infection, and nerve damage; as well as minimizing the need for unnecessary fasciotomies.