Rhythm

Alchem ​​International Solves Stability Problems in Micronized Digoxin and Files Patent for New Manufacturing Process

GENEVA, April 25, 2019 / PRNewswire / – Alchem ​​International Private Limited (“Alchem”), a privately held pharmaceutical company specializing in the production of plant-derived active pharmaceutical ingredients (APIs), today announced the launch of its platform owner of micronized digoxin. The Alchem ​​molecule is the only micronized digoxin available worldwide that […]

Endotronix Receives ISO 13485:2016 Certification

LISLE, Ill., April 24, 2019 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced that the company received ISO 13485:2016 certification from British Standards Institution (BSI) for its Quality Management System (QMS). Endotronix’s adherence to internationally recognized standards for the […]

AtriCure Announces First Patient Enrollment in the DEEP IDE Trial Restart

MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatment for atrial fibrillation (Afib) and left atrial appendage management, today announced the restart of the Dual Epicardial and Endocardial Procedure (DEEP) clinical trial (NCT02393885). Following approval by the FDA to restart the trial and enroll an additional 40 subjects, […]

FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device

MOUNTAIN VIEW, Calif., April 23, 2019 /PRNewswire/ — AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced two additional FDA 510(k)-cleared indications, making KardiaMobile the only consumer ECG device in the world with FDA-clearance to detect the three most common heart arrhythmias. In addition to detecting Atrial Fibrillation (AFib) and Normal Sinus […]

BioSig Completes Successful Patient Cases at Greenville Memorial Hospital

Santa Monica, CA, April 16, 2019 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address unmet needs for the electrophysiology (EP) marketplace, today announced that the Company successfully conducted patient cases using PURE EP(tm) System at Greenville Memorial Hospital, […]

Omron Healthcare Announces April 15th Pre-Order Availability of Complete™, the First Blood Pressure Monitor with EKG Capability

LAKE FOREST, Ill., April 11, 2019 /PRNewswire/ — Omron Healthcare, Inc., the global leader in personal heart health and wellness technology, has secured FDA clearance on its new Complete™, the first blood pressure monitor with EKG capability in a single device, and will open pre-orders on April 15th at 12:00 pm CST in the U.S. on OmronHealthcare.com. […]

Stryker Launches LIFEPAK® CR2 Defibrillator with LIFELINKcentral™ AED Program Manager in the United States

REDMOND, Wash., USA, April 11, 2019 /PRNewswire/ — Stryker has launched the company’s newest defibrillation solution, the LIFEPAK® CR2 defibrillator with LIFELINKcentral™ AED program manager, in the United States. The company has announced that the LIFEPAK CR2 automated external defibrillator (AED) has received Premarket Approval (PMA) by FDA. The LIFPAK CR2 AED was previously released […]

Medtronic HeartWare(TM) HVAD(TM) System Demonstrates Reduction in Total Strokes, Disabling Strokes and Stroke-Related Mortality with Blood Pressure Management

DUBLIN and ORLANDO, Fla. – April 5, 2019 – Medtronic plc (NYSE:MDT) today announced the results of an analysis on the impact of stroke severity in patients receiving its HeartWare(TM) HVAD(TM) System as destination therapy, showing that targeted blood pressure management helped reduce serious strokes. The HVAD System is a left […]

HeartMate 3 heart pump reduces burden of bleeding and stroke rates, eliminates pump thrombosis

Orlando, Fla., April 04, 2019 (GLOBE NEWSWIRE) — Patients with a newer version of a common heart pump experienced a reduced aggregate burden of bleeding and stroke rates – and no pump thrombosis requiring surgical exchange, compared to patients with the predecessor device.  The MOMENTUM3 study was a randomized controlled […]

Journal of Heart and Lung Transplantation releasing themed issue on MCS to coincide with ISHLT 2019

Orlando, Florida, April 03, 2019 (GLOBE NEWSWIRE) — The Journal of Heart and Lung Transplantation is releasing its themed issue on Mechanical Circulatory Support to coincide with the 39th Annual Meeting of the International Society for Heart and Lung Transplantation being held April 3 – 6 in Orlando, Florida.  This special issue highlights […]