Rhythm

LivaNova Receives U.S. FDA 510(k) Clearance for LifeSPARC Advanced Circulatory Support System

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Advanced Circulatory Support (ACS) pump and controller, the LifeSPARC system. Derived from more than 20 years of life support experience with TandemLife, LifeSPARC […]

BioSig Technologies, Inc. to Receive 15 Units of PURE EP™ System from Manufacturer for Commercial Installation – Corrected Version

Westport, CT, July 15, 2019 (GLOBE NEWSWIRE) — 1) New units to be prepped for next phase of targeted commercial launch strategy 2) Company includes 3 additional hospitals to its list of medical institutions for delivery in 2019 to demonstrate the technology 3) Proprietary device is designed to record and display […]

Endotronix Enrolls First Patient in SIRONA II CE Mark Trial

LISLE, Ill., July 15, 2019 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced enrollment of the first patient in its prospective, multi-center, SIRONA II trial, in Europe. The 60-patient study will evaluate safety and efficacy of the Cordella™ Pulmonary Artery Pressure Sensor System […]

Publication of UNCOVER AF Study in Circulation Demonstrates Impact of Charge Density Mapping During AF Ablation

CARLSBAD, Calif., July 11, 2019 /PRNewswire/ — Acutus Medical today announced the publication of the UNCOVER AF study in Circulation: Arrhythmia and Electrophysiology. The study demonstrated 73 percent single-procedure freedom from atrial fibrillation (AF) at 12 months with the use of Acutus’ AcQMap advanced cardiac imaging and mapping system. Acutus develops next-generation electrophysiology (EP) technology […]

Medtronic HeartWare(TM) HVAD(TM) Implanted via Less Invasive Thoracotomy Shows 95 Percent Freedom from Disabling Stroke at Two Years

DUBLIN, July 08, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced two-year outcomes from the LATERAL clinical trial evaluating the use of its HeartWare™ HVAD™ System in patients who received the system via a less-invasive, thoracotomy implant approach. The HVAD System is a heart pump, called a left ventricular assist device […]

BIOTRONIK Receives FDA Clearance on Next-Gen Injectable Cardiac Monitor: BIOMONITOR III

LAKE OSWEGO, Ore., July 8, 2019 /PRNewswire/ — BIOTRONIK today announced FDA clearance of the BIOMONITOR III injectable cardiac monitor (ICM). BIOMONITOR III is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatment. Early detection of arrhythmia through ICMs enables physician intervention before adverse outcomes occur. Atrial fibrillation […]

Philips ships two-millionth AED, helping to save lives across the globe

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced shipment of its two-millionth AED (Automated External Defibrillator), which was delivered to a customer in Italy. This achievement marks a major milestone in almost 20 years of Philips innovation in cardiac resuscitation aimed at […]

With Innovative Health’s landmark clearance to reprocess the leading electrophysiology mapping catheter from Biosense Webster, single-use device reprocessing has entered a new era.

SCOTTSDALE, Ariz., June 28, 2019 /PRNewswire-PRWeb/ — Innovative Health, the leading single-use cardiology medical device reprocessing company, today announced it has received FDA clearance for reprocessing the market-leading PENTARAY® Nav eco High-Density mapping catheter (hereinafter PentaRay), a development that represents both a technological and healthcare cost reduction milestone. The PentaRay is a key […]

CorWave to Report First Successful In Vivo Survival at 30-Day Milestone with Its Innovative LVAD Cardiac Support Device

CLICHY, France–(BUSINESS WIRE)–CorWave announced today that results from chronic preclinical studies to evaluate its Left Ventricular Assist Device (LVAD) will be presented at the 65th Annual Conference of the American Society for Artificial Internal Organs (ASAIO) in San Francisco. The poster presentation, entitled “Low Shear, High Flow, and Physiologic Pulsatility: […]

BIOTRONIK Launches Next Generation Injectable Cardiac Monitor in the CE Region

BERLIN–(BUSINESS WIRE)–BIOTRONIK today announced the market release of its new injectable cardiac monitor (ICM), BIOMONITOR III, following approval in the CE region. The novel device is designed to help patients with irregular heart rhythms by documenting suspected arrhythmia or unexplained syncope with increased clarity. As the most common type of arrhythmia, 33.5 […]