Penumbra Inc. Recalls 3D Revascularization Device Due to Wire Material That May Break or Separate During Use Penumbra Inc. is recalling the Penumbra 3D Revascularization device because there is a risk of the delivery wire breaking or separating during use. Fractured pieces of the delivery wire could be left inside […]
Regulatory
Intact Vascular Release: FDA Approves 6-Month Primary Endpoint For The Tack Endovascular System In Below The Knee Disease
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial from 12 months to […]
Cerus Endovascular Receives CE Mark Approval For The Contour Neurovascular System For The Treatment Of Intra-Cranial Aneurysms
FREMONT, Calif. and OXFORD, United Kingdom, July 6, 2017 /PRNewswire/ — Cerus Endovascular Ltd. today announced that it has received CE Mark approval for the commercial sale of its Contour Neurovascular System for the treatment of intra-cranial aneurysms (IAs) across the European Union (EU). The Contour Neurovascular System is a unique, fine mesh braid […]
“Cardiologs ECG Analysis Platform” Receives FDA Clearance
PARIS–(BUSINESS WIRE)–Cardiologs Technologies SAS announced today that it has received FDA clearance of its Cardiologs ECG Analysis Platform, a cloud-based cardiac monitoring-analysis web service powered by artificial intelligence (AI). Cardiologs aids physicians in screening for atrial fibrillation (AFib) and other arrhythmias using long-term ambulatory ECG monitoring recordings. The Cardiologs system is also CE-marked […]
HeartFlow Announces American Medical Association Issues Unique Category III CPT Codes For HeartFlow FFRct
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 coronary artery disease (CAD). The CPT code application was submitted […]
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, […]
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 patient at risk. Augmented reality (AR) is one technology that […]
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 […]
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