Rhythm

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 […]

AUM CARDIOVASCULAR RECEIVES FDA CLEARANCE FOR REVOLUTIONARY DIAGNOSTIC HEART DEVICE

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 […]