Rhythm

Bardy Diagnostics Earns Acclaim from Frost & Sullivan for Its Groundbreaking Carnation Ambulatory Monitor™ Patch for Arrhythmia Monitoring

SANTA CLARA, California, May 6, 2019 /PRNewswire/ — Based on its recent analysis of the North American remote cardiac monitoring market, Frost & Sullivan recognizes Bardy Diagnostics, Inc. (BardyDx) with the 2019 North America Technology Innovation Award for its Carnation Ambulatory Monitor™ (CAM™) patch. The CAM™ patch is a first-of-its-kind P-wave-centric surface electrocardiograph (ECG) arrhythmia […]

Focusing on Women: BIOTRONIK Launches Study to Understand the Impact of ICDs in NICM Patients

LAKE OSWEGO, Ore., May 6, 2019 /PRNewswire/ — BIOTRONIK today announced initial enrollment into the BIO-LIBRA study, a first-of-its kind, large-scale prospective study to analyze sex-specific outcomes in patients with non-ischemic cardiomyopathy (NICM) treated with cardiac defibrillator device therapy. To adequately analyze whether women and men respond differently to defibrillator therapy, a minimum of […]

Abbott Launches Next-generation Detection Technology in the U.S. and Europe, Offering a Smarter Approach to 24/7 Heart Monitoring for People with Irregular Heartbeats

ABBOTT PARK, Ill., May 6, 2019 /PRNewswire/ — Abbott today announced the launch of a new, smarter heart monitor for better arrhythmia detection—positive news for people at risk for irregular heartbeats. Now with CE Mark in Europe and U.S. Food and Drug Administration (FDA) clearance, the next-generation Confirm Rx™ insertable cardiac monitor (ICM), a paperclip-sized implantable […]

SentreHEART Receives CE Mark for LARIAT-RS™ 50mm and Expanded Indication for Left Atrial Appendage Exclusion

REDWOOD CITY, Calif.–(BUSINESS WIRE)–SentreHEART, Inc., announced it has received CE Mark for the LARIAT-RS™ 50mm as well as expanded labeling for the LARIAT-RS for left atrial appendage (LAA) exclusion. The new 50mm device along with the 45mm LARIAT-RS is now available for sale in Europe. The LARIAT-RS (LARIAT) device is […]

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. […]