Rhythm

Biobeat Remote Patient Monitoring Devices and Platform Receive Additional FDA Clearances for Stroke Volume and Cardiac Output

PETAH TIKVA, Israel, Jan. 9, 2023 /PRNewswire/ — Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that its wearable remote patient monitoring devices have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to monitor stroke volume and cardiac output in addition to cuffless […]

Cardiac Insight’s Cardea SOLO™ Wearable ECG System Chosen for Stanford Medicine Study to Measure Atrial Fibrillation in Older Women

BELLEVUE, Wash.–(BUSINESS WIRE)–Cardiac Insight, Inc., a leading healthcare innovator specializing in prescription-based wearable cardiac sensors and automated electrocardiogram (ECG) analysis software for cardiac arrhythmia diagnosis, today announced that researchers at Stanford Medicine selected the company’s Cardea SOLO™ wearable ECG system for a medical study entitled: Serial 7-Day Electrocardiogram Patch Screening for Atrial Fibrillation […]

HeartBeam Granted European Patent for Signal Transformation from Vector Electrocardiogram (VECG) to 12-Lead Electrocardiogram (ECG)

Patented Technology Provides Protection for HeartBeam AIMIGo™ Credit Card-sized Device in European Market SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector ECG platform for heart attack detection anytime, anywhere, announced today that its patent that enables generation of a synthesized […]

CES 2023: OMRON Healthcare Reaches 50 Years of Heart Health Leadership, Unveils New U.K. Remote Patient Monitoring Service, and Sets Sights on the AFib Epidemic

Global heart health leader charts path forward in its Going for Zero mission with RPM services Viso and VitalSight and builds on breakthrough innovations transforming the global heart health market HOFFMAN ESTATES, Ill., Jan. 4, 2023 /PRNewswire/ — OMRON Healthcare, Inc., the global leader in remote blood pressure monitoring and personal health technology, is […]

First Patient Enrolled in Phase 3 Trial Evaluating Abelacimab in High-Risk Patients with Atrial Fibrillation Deemed Unsuitable for Current Anticoagulants

FDA Fast-Track designation was granted to investigate abelacimab for the prevention of stroke and systemic embolism in patients with atrial fibrillation LILAC-TIMI 76 trial is the third Phase 3 study with abelacimab initiated by Anthos Therapeutics Abelacimab is a dual-acting, once-monthly, fully human monoclonal antibody targeting both Factor XI and […]

Acutus Medical Announces Acceptance of the AcQForce Flutter Abstract for Presentation during the Late-Breaking Clinical Trials and First Report Investigations sessions at the 2023 AF Symposium

CARLSBAD, Calif., Dec. 29, 2022 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the acceptance of the AcQForce Flutter abstract titled “AcQForce Flutter Trial Clinical Results: Force Sensing RF Ablation with Low […]

Owlet Announces FDA Software-as-a-Medical Device Submission for Heart Rate and Oxygen Displays and Notifications

Owlet submitted a de novo classification request to the FDA for an over-the-counter software-as-a-medical-device that offers heart rate and oxygen displays and notifications in conjunction with Owlet’s existing Dream Sock sleep monitoring capabilities. December 22, 2022 04:05 PM Eastern Standard Time LEHI, Utah–(BUSINESS WIRE)–Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that the U.S. […]

FDA Approves Impella ECP Pivotal Heart Pump and First Patients Enrolled in Pivotal Clinical Trial

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces the United States Food and Drug Administration (FDA) has approved the version of Impella ECP that will be used in the Impella ECP Pivotal Trial, and the first two patients have been enrolled in the trial. Amir Kaki, MD, director of mechanical circulatory support at […]

Aerami Therapeutics Announces Completion of Dosing in Phase 1 Trial of AER-901 (inhaled imatinib), a Critical Milestone Toward the Planned Initiation of a Phase 2 Trial in Pulmonary Arterial Hypertension (PAH) During the First Half of 2023

AER-901 (inhaled imatinib), a potential reverse-remodeling therapy, is being developed to address unmet need for PAH treatments that target pulmonary vascular remodeling while supporting ease-of-use for patients. PAH is a rare and progressive disease with no cure; pulmonary vascular remodeling is believed to drive disease progression and poor outcomes, however, […]

Corewell Health Grows Robotic Program to Treat Heart Rhythm Disorders with Adoption of Stereotaxis’ Genesis System

ST. LOUIS, Dec. 20, 2022 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), the global leader in robotic technologies for the treatment of cardiac arrhythmias, today announced the successful treatment of patients using the latest Genesis Robotic Magnetic Navigation (RMN) system by physicians of the nationally recognized Fred & Lena Meijer Heart […]