REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that the American Medical Association (AMA) has issued a set of new Category III Current Procedural Terminology (CPT®) codes for HeartFlow® FFRct, a first-of-its-kind noninvasive technology that helps clinicians diagnose and treat patients with suspected […]
Regulatory
Edwards Lifesciences (EW)’ INSPIRIS RESILIA Valve Wins FDA Approval
IRVINE, Calif., July 5, 2017/PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it received U.S. Food and Drug Administration (FDA) approval for its INSPIRIS RESILIA aortic valve, […]
USC’s Digital Health Expert Provides Critical Physician Insights On Cybersecurity and Medical Devices Panel Discussion in the Nation’s Capital
NEWS PROVIDED BY USC Center for Body Computing 11:51 ET WASHINGTON, June 30, 2017 /PRNewswire-USNewswire/ — This week in the nation’s capital the Bipartisan Policy Centerconvened thought leaders in national security and health care including Leslie Saxon, MD, cardiologist at Keck Medicine of USC and executive director of the USC […]
Health insurance expansion linked to fewer sudden cardiac arrests
NEWS PROVIDED BY Oregon Health & Science University 28 Jun, 2017, 17:20 ET PORTLAND, Ore. and LOS ANGELES, June 28, 2017 /PRNewswire/ — The incidence of sudden cardiac arrest, an often deadly loss of heart function, declined significantly among previously uninsured adults who acquired health insurance through […]
What is AR and How is it Disrupting Healthcare?
JUNE 28, 2017 BY KEN DROPIEWSKI (KEN@PRIME-CORE.COM) Real-time information is critical while performing a procedure. Doctors often require data from outside sources to proceed in a difficult situation. But obtaining such information during an intervention can be problematic and may even place the […]
FDA Green Lights ClearFlow’s FlowGlide Technology for Cardiac Surgery Patients
ANAHEIM, Calif.–(BUSINESS WIRE)–ClearFlow, Inc., a medical device company based in Anaheim, California, announced today that the United States Food & Drug Administration (FDA) has granted 510[k] clearance for the company’s proprietary FlowGlide™ Active Clearance Technology® System. “The new design helps […]
Veeva Systems, Inc. Release: Industry Survey Reveals 99% Of Clinical Operations Leaders Report The Need To Unify Their Clinical Applications
BARCELONA, Spain–(BUSINESS WIRE)–There is an industrywide drive toward a unified clinical operating model, according to the Veeva 2017 Unified Clinical Operations Survey, one of the industry’s largest annual surveys of clinical operations professionals. The new research from Veeva Systems (NYSE: […]
Cagent Vascular Completes Enrollment of PRELUDE Study Using Serranator Device
WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, including the FDA 510(k) cleared Serranator® Alto PTA Serration Balloon Catheter, announces the completion of enrollment in the First-in-Human PRELUDE Study. The purpose […]
Medtronic Enrolls First Patient in Study of IN.PACT(TM) AV Access Drug-Coated Balloon in Patients with End-Stage Renal Disease
GlobalNewsWire DUBLIN – May 24, 2017 – Medtronic plc (NYSE: MDT) today announced that the first patient has been enrolled in the IN.PACT(TM) AV Access Drug-Coated Balloon (DCB) study for use in patients with end-stage renal disease (ESRD). The U.S. […]
Shockwave Medical Snags CE Mark for Coronary Lithoplasty System
FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today announced conformité européenne (CE) Mark for the company’s Coronary Lithoplasty® System for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery […]