Rhythm

First-of-its-Kind Large Access Dilator Launches in U.S., Following Cleveland Clinic Case

TORONTO, May 2, 2019 /PRNewswire/ – Baylis Medical announced today the U.S. launch and first clinical use of its ExpanSure™ Transseptal Dilation System, used in a left-atrial appendage (LAA) closure case performed at the Cleveland Clinic, in Cleveland, Ohio. The ExpanSure dilator combines a sheath and dilator into a single tool, and facilitates larger […]

Medtronic Receives FDA Approval for CareLink SmartSync Device Manager

DUBLIN – May 2, 2019 – Medtronic plc (NYSE:MDT) today announced that the company has received U.S. Food and Drug Administration (FDA) approval for the CareLink SmartSync(TM) Device Manager. With the introduction of SmartSync, physicians will now be able to use an Apple® iPad® to program and manage data from Medtronic’s BlueSync-enabled […]

Sotera Wireless to Showcase Its Life-Saving ViSi Mobile 1.5G at the 2019 IHI Patient Safety Congress

SAN DIEGO–(BUSINESS WIRE)–Sotera Wireless, maker of the ViSi Mobile® Surveillance Monitoring System will be exhibiting at the Institute for Healthcare Improvement Patient Safety Congress (IHI) on May 15-17 in Houston, TX. The IHI Patient Safety Congress brings together people who are passionate about providing the highest quality care and patient […]

GENETIC-AF Phase 2B Trial Results Published in the Journal of American College of Cardiology: Heart Failure

WESTMINSTER, Colo., May 01, 2019 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that the paper “GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure Population” was published in JACC: Heart Failure, a journal […]

Biofourmis’ RhythmAnalytics™ Platform Receives FDA Clearance for AI-Based Automated Interpretation of Cardiac Arrhythmias

BOSTON, April 30, 2019 /PRNewswire/ — Biofourmis announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its RhythmAnalyticsTM platform, a cloud-based software for automated interpretation of cardiac arrhythmias. It uses an enhanced deep-learning technique to detect over 15 types of cardiac arrhythmias along with beat-by-beat morphology computation which […]

Omron Healthcare Launches Complete™, the First Blood Pressure Monitor with EKG Capability in a Single Device, for Retail Sale

LAKE FOREST, Ill., May 1, 2019 /PRNewswire/ — Omron Healthcare, Inc., the number one doctor and pharmacist recommended blood pressure brand, today launched Complete™, the first blood pressure monitor with EKG capability in a single device, for retail sale in the U.S. online at OmronHealthcare.com. Complete recently received FDA clearance as a medical device. […]

Medtronic Receives FDA Approval for World’s First Quadripolar Active Fixation Left Heart Lead

DUBLIN – May 1, 2019 – Medtronic plc (NYSE:MDT) announced it has received U.S. Food and Drug Administration (FDA) approval 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 is the only active-fixation left […]

VivaQuant Receives FDA 510(k) Clearance for its RX-1 Rhythm ExpressTM Arrhythmia Device

ST. PAUL, Minn.–(BUSINESS WIRE)–VivaQuant, a digital health company with powerful technology to accurately and efficiently identify and report cardiac arrhythmias, has received FDA clearance for its RX-1 wearable device. RX-1 continuously monitors a patient’s ECG as they go about their normal daily activities, identifies arrhythmias, and communicates the information to […]

Murj 2.0 Gives Cardiologists a 360-Degree Implantable Device Patient View

SANTA CRUZ, Calif., April 30, 2019 (GLOBE NEWSWIRE) — Murj, the digital healthcare company providing Software-as-a-Service (SaaS) cardiac implantable electronic device (CIED) management, announced today the immediate availability of Murj 2.0. This revolutionary implantable cardiac device management software empowers clinicians to deliver superior patient care in ways never before possible. […]

Precision Optics Corporation, Inc. Announces Receipt of $2.2 Million Order For Custom Designed Cardiovascular Endoscope

GARDNER, Mass., April 29, 2019 (GLOBE NEWSWIRE) — Precision Optics Corporation, Inc. (OTCQB: PEYE) today announced that it has received a follow-on order totaling $2,216,000 from CardioFocus, Inc. for the manufacture of a cardiovascular endoscope to support the HeartLight Endoscopic Ablation System. Deliveries are scheduled to be made over two […]