Rhythm

Cardiac Insight Announces Expansion Into More Than 20 Asia-Pacific Markets with i.SigNal by Dreamtech Partnership

Dreamtech distributes Cardea SOLO™ ECG System in Korea through its new healthcare organization iSigNal, and lead commercial expansion in 20+ other APAC countries. BELLEVUE, Wash. & SEONGNAM, South Korea–(BUSINESS WIRE)–Cardiac Insight, Inc., a digital health innovator specializing in wearable cardiac sensors and automated electrocardiogram (ECG) analysis software announced today that […]

CardioFocus Announces Agreement with China Grand Pharmaceutical to Bring HeartLight X3 System to China

– China Grand Pharma will seek regulatory approvals and commercialize CardioFocus’ innovative catheter ablation technology for pulmonary vein isolation – Pulmonary vein isolation is the gold standard treatment for atrial fibrillation MARLBOROUGH, Mass., June 2, 2021 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatments for atrial fibrillation (AFib), […]

Edwards Receives Clearance For Hypotension Prediction Index Software For Noninvasive Acumen IQ Cuff

IRVINE, Calif., June 1, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced that Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff has received U.S. Food and Drug Administration clearance. This is the first noninvasive solution that unlocks Acumen HPI software and uses machine learning to alert clinicians of the […]

AliveCor Acquires CardioLabs and Sets the Stage for the Launch of Advanced Ambulatory Monitoring Services

MOUNTAIN VIEW, Calif., June 2, 2021 /PRNewswire/ — AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced that it has acquired the independent diagnostic testing facility (IDTF) CardioLabs, a leading monitoring and cardiac diagnostic service provider. The acquisition is a cornerstone of AliveCor’s mission to extend its comprehensive […]

Acutus Medical Receives FDA Approval to Initiate US Atrial Fibrillation IDE Trial with the AcQBlate® FORCE Sensing Ablation System

CARLSBAD, Calif., May 27, 2021 (GLOBE NEWSWIRE) — Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced FDA approval for the company to initiate its Atrial Fibrillation (“AF”) Investigational Device Exemption (IDE) clinical trial for the AcQBlate Force […]

Varian Receives FDA “Breakthrough Device Designation” for its Cardiac Radioablation (CRA) System for Treatment of Refractory Ventricular Tachycardia (VT)

– Varian’s CRA system has been designated a “breakthrough device” by the FDA because of its potential to offer a more effective treatment for select patients with refractory VT. – Technology being developed will be assessed in clinical studies as a noninvasive treatment for select patients with refractory VT. PALO […]

Biobeat Launches Wearable Continuous Ambulatory Blood Pressure Monitoring (ABPM) Device

New Clinical Data Supports Use of Biobeat ABPM Cuffless-Monitor as Reliable and Accurate Solution for Out-of-Clinic Blood Pressure Monitoring PETAH TIKVA, Israel, May 26, 2021 /PRNewswire/ — Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today the launch of its new wearable and continuous ambulatory blood pressure […]

iRhythm® Technologies Continues to Fuel Innovation in Cardiac Monitoring and Unveils Two FDA Clearances for Superior Patient Care

The new Zio® monitor is designed to significantly improve patient comfort, while enhanced AI capabilities raise the bar on cardiac arrhythmia detection SAN FRANCISCO, May 24, 2021 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today announced […]

Spacelabs Healthcare Introduces Lifescreen Pro for Rapid Analysis of Arrhythmia Events

SNOQUALMIE, Wash.–(BUSINESS WIRE)–Spacelabs Healthcare (the “Company” or “Spacelabs”), a division of OSI Systems, Inc. (“OSI Systems”) (NASDAQ: OSIS), today announced the release of Lifescreen™ Pro event screening system. Lifescreen Pro expands the Company’s non-invasive cardiology offerings, which include Spacelabs Pathfinder SL ambulatory ECG analysis system. Building on 40 years of technology, design, […]

Acceleron Presents Preliminary Data from the SPECTRA Phase 2 Trial of Sotatercept in Pulmonary Arterial Hypertension (PAH) at the American Thoracic Society 2021 International Conference

– Treatment with sotatercept in the ongoing SPECTRA Phase 2 trial was associated with improvements in resting and exercise hemodynamics at week 24 – – Sotatercept was generally well tolerated, consistent with the previously reported safety profile in PAH and in other diseases – – Company-hosted investor and analyst conference […]