Pression Receives FDA 510(k) Clearance for Wave PRO™ External Counter-Pulsation System
Pression, Inc., a medical technology innovator specializing in non-invasive circulatory health, announced today that it has received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) for its Wave PRO™ External Counter-Pulsation (ECP) System. This milestone clearance allows Pression to commercially market its patented, cardiac-gated compression technology for...
Cardiology’s New Pillar: Why ECP is No Longer an “Alternative” (2025 Year in Review)
The landscape of External Counterpulsation (ECP) underwent a significant transformation in 2025, evolving from a "last-resort" treatment for refractory angina into a front-line therapy for microvascular disease, cognitive health, and post-viral recovery....
Pression Submits 510(k) to FDA
Following the successful conclusion of our WaveCREST Clinical Study, we are very proud to announce the submission of our 510K to FDA. This tremendous milestone was made possible through the tireless effort of our fantastic team and our partners. We look forward to bringing a non-invasive, cost-effective solution to...