Regulatory

Terumo Cardiovascular Group Announces 510(k) Clearance for the CDI® Blood Parameter Monitoring System 550, Adding New Parameter for Oxygen Delivery

ANN ARBOR, Mich., Nov. 14, 2018 /PRNewswire/ — Terumo Cardiovascular Group, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI® Blood Parameter Monitoring System 550, adding real-time monitoring of […]

MEDTRONIC BEGINS RENAL DENERVATION STUDY FOR HIGH BLOOD PRESSURE PATIENTS PRESCRIBED ANTI-HYPERTENSIVE MEDICATION

DUBLIN – November 8, 2018 – Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval to begin a clinical trial to evaluate the Symplicity Spyral(TM) renal denervation system in patients with high blood pressure (hypertension) who are already […]

ABBOTT’S HEARTMATE 3 HEART PUMP NOW FDA APPROVED FOR ADVANCED HEART FAILURE PATIENTS NOT ELIGIBLE FOR A HEART TRANSPLANT

ABBOTT PARK, Ill., Oct. 19, 2018 /PRNewswire/ — Abbott (NYSE: ABT) announced today that the HeartMate 3™ Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. With the approval, physicians […]

MC3 Cardiopulmonary Announces FDA Clearance of Crescent™ for Veno-Venous Extracorporeal Membrane Oxygenation (ECMO)

DEXTER, Mich., Oct. 18, 2018 /PRNewswire/ — MC3 (mc3corp.com) today announced the launch of the Crescent™Jugular Dual Lumen Catheter, the first such device cleared by FDA for ECMO (Extracorporeal membrane oxygenation) in the United States. MC3’s Crescent catheter is placed through the jugular […]