Aziyo Completes Enrollment in Prospective Post Market Study of CanGaroo ECM Envelope

SILVER SPRING, Md.–(BUSINESS WIRE)–Aziyo Biologics, Inc. a fully integrated regenerative medicine company, today announced completion of patient enrollment in SECURE, a prospective post market study of 1,000 patients treated with CanGaroo® ECM® Envelope in conjunction with cardiac implantable electronic device (CIED) placement. The CanGaroo ECM Envelope is intended to securely hold a […]

Abbott (ABT) Introduces Heartmate 3 Left Ventricular Assist System – The Latest Milestone In Therapy For Advanced Heart Failure Patients

ABBOTT PARK, Ill., Aug. 28, 2017 /PRNewswire/ — Abbott (NYSE: ABT) announced today it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left Ventricular Assist System (also known as an LVAD). The HeartMate 3 system provides a new option for physicians managing advanced heart failure patients in need […]

Medtronic Receives CE Mark for Attain Stability(TM) Quad MRI SureScan(TM) Active-Fixation Heart Lead

DUBLIN – August 21, 2017 – Medtronic plc (NYSE: MDT) announced it has received CE (Conformité Européene) Mark for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead features novel, active-fixation technology that is designed […]

Implanted Cardiac Device: Newest Ransomware Target

by Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) It has the makings of a plot for a blockbuster movie: a high ranking government official or world leader assassinated by a nefarious hacker who remotely accesses an implanted cardiac device. Plot lines and prominent world leaders notwithstanding, cyber-security risks for implantable cardiac […]

Cardiome Provides U.S. Regulatory Update For BRINAVESS

VANCOUVER, Aug. 21, 2017 /PRNewswire/ – Cardiome Pharma Corp. (NASDAQ: CRME/ TSX:COM) today announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the regulatory path for BRINAVESS® (vernakalant hydrochloride, IV), the Company’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF).  In its […]

BIOTRONIK US Launches Smallest MR Conditional Quadripolar Cardiac Resynchronization Therapy Pacemaker

LAKE OSWEGO, Ore., Aug. 21, 2017 /PRNewswire/ — BIOTRONIK today announced FDA approval and commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P) with MRI AutoDetect technology. With a volume of 15 cc, Edora HF-T QP is the smallest MR conditional CRT-P available in the US with […]

HeartSciences Announces CE Mark and European Launch of MyoVista® High Sensitivity ECG Device

WESTLAKE, Texas, Aug. 17, 2017 /PRNewswire/ — HeartSciences today announced the European launch of MyoVista® high sensitivity electrocardiograph (hsECG™) Testing Device, developed in response to the global unmet need for effective, low-cost, front-line screening of cardiac disease in both symptomatic and asymptomatic patients. MyoVista measures the heart’s energy during each […]


NORTHFIELD, MINNESOTA— AUM Cardiovascular announced that it has received clearance from the Food and Drug Administration for CADence,™ a non-invasive acoustic and ECG device designed to help physicians detect physiological and pathological heart murmurs. The reusable, non-invasive, radiation-free handheld device, which is now available in the United States, records sounds […]

Boca Raton Regional Hospital Using New Technology To Map Irregular Heart Rhythms Non-Invasively

NEWS PROVIDED BY Boca Raton Regional Hospital  Aug 01, 2017, 12:24 ET BOCA RATON, Fla., Aug. 1, 2017 /PRNewswire-USNewswire/ — Boca Raton Regional Hospital is the first in Florida and one of only five centers nationally to non-invasively map irregular heartbeats in patients with chronic atrial fibrillation and other arrhythmias who have not responded adequately […]

CardioFocus® Receives Approval For HeartLight® Endoscopic Ablation System From The Japanese Ministry Of Health, Labour And Welfare

MARLBOROUGH, Mass., July 31, 2017 /PRNewswire/ — CardioFocus, Inc. today announced that the Japanese Ministry of Health, Labour and Welfare has approved the HeartLight Endoscopic Ablation System for the treatment of paroxysmal atrial fibrillation (AF) in Japan. The HeartLight System is a visually guided laser balloon technology for controlled and consistent pulmonary vein isolation (PVI) […]