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, the first in a new class of resilient heart valves. […]

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 Center for Body Computing, for a panel discussion, “Cybersecurity and […]

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 the Affordable Care Act, a new study shows. The findings, […]

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 resist kinks, and allows positioning of the catheters into harder-to-reach […]

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: VEEV) reveals that nearly all respondents cite the need to […]

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 of this prospective, single-arm, multicenter feasibility study is to show […]

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. Food and Drug Administration (FDA) approved the investigational device exemption […]

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 disease. The Shockwave Medical Coronary Lithoplasty System is an innovative […]