Sensydia Receives FDA Breakthrough Device Designation for CPSTM Non-Invasive Cardiac Monitoring Device
/Sensydia, an innovator in rapid, non-invasive measurement of critical cardiac function, today announced that its Cardiac Performance System (CPSTM) has been granted Breakthrough Device Designationby the United States Food and Drug Administration (FDA). As part of this Breakthrough Device Designation, the FDA will work closely with Sensydia to expedite the development of CPS and prioritize the review of subsequent regulatory submissions.
CPS is a non-invasive cardiac monitoring device that reports critical heart performance measurements to physicians for comprehensive evaluation of patients with advanced and persistent heart failure, without requiring an in-hospital catheterization procedure or ultrasound assessment.