COATESVILLE, PA, January 5, 2026 (EZ Newswire) -- Pression, Inc., a medical technology innovator specializing in noninvasive 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 the treatment of patients with chronic stable angina (CSA). By synchronizing external pressure with the patient’s heart rhythm, the Wave PRO offers a smart, portable solution designed to enhance blood flow and improve quality of life for those suffering from debilitating cardiovascular symptoms.
With this milestone, Pression moves into commercial manufacturing, distribution, and engagement with healthcare providers in outpatient and cardiac rehabilitation settings.
"Receiving FDA 510(k) clearance for the Pression Wave PRO is a definitive turning point for our company and, more importantly, for the millions of patients living with chronic stable angina," said Adam Salamon, CEO of Pression. "This technology began as a way to enhance performance in the military, and today, it is a cleared medical solution that brings the benefits of cardiac-gated compression out of the clinic and directly to outpatient care. Our mission has always been to make life-enhancing circulation therapy accessible, comfortable, and smart. With this clearance, we are ready to begin the next chapter of cardiovascular care in the United States.”