Rhythm

Eko Launches First AI-Powered Telehealth Platform for Virtual Pulmonary and Cardiac Exams, Providing Clinicians with In-Person Level Exam Capabilities During Video Visits

Used by more than 200 health systems for telehealth, platform goes beyond standard video conferencing to facilitate stethoscope audio, ECG live-streaming and FDA-cleared identification of atrial fibrillation (AFib) and heart murmurs Patients can video chat with their providers and navigate self-operated stethoscope exams OAKLAND, Calif.–(BUSINESS WIRE)–Eko today announced Eko Telehealth, the first […]

VSMS ECG Patch receives US FDA ‘Emergency Use Authorisation’ for patients being treated for COVID-19

Patch now authorised in the USA for emergency use for patients undergoing treatment for COVID-19 Patch entitled for reimbursement under US CPT code scheme – adds to GMV’s growing revenue profile Large addressable market for G Medical – ~1.5m confirmed cases of COVID-19 recorded in the US[i] so far Fast route to market […]

HeartHero Partners With Sudden Cardiac Arrest Survivor

The story and voice inside HeartHero’s Elliot DENVER–(BUSINESS WIRE)–HeartHero’s industry disruptive Automated External Defibrillator (AED), Elliot, has found its voice in Sudden Cardiac Arrest Survivor Carrie “Zapgirl” Romero. Drawn to HeartHero’s name and mission, Romero, a professional Voice Actor, long-time AED Advocate, and ICD patient, reached out to HeartHero’s CEO […]

Thermedical’s Groundbreaking SERF Ablation System Earns FDA’s Breakthrough Device Designation

WALTHAM, Mass.–(BUSINESS WIRE)–Thermedical®, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter. The FDA Breakthrough Devices Program is intended to help patients […]

Clinical Study Shows Cardiologs’ AI Reduces The False Positive Burden Of Implantable Loop Recorders By Almost 70%

Data presented at HRS 2020 shows Cardiologs’ AI-system successfully eliminates more than two-thirds of atrial fibrillation false positives from ILR reports, alleviating the clinical burden associated with remote monitoring PARIS and BOSTON, May 14, 2020 /PRNewswire/ — Cardiologs, a global leader in artificial intelligence (AI) for cardiac diagnostics, today in partnership with the Valley Health […]

FDA Issues Emergency Use Authorization for Eko’s ECG-based Low Ejection Fraction Screening Algorithm, Designed to Improve Detection of Heart Failure During COVID-19 Pandemic

Developed with Mayo Clinic, the algorithm helps identify low ejection fraction – a sign of heart failure and a significant comorbidity for COVID-19 patients OAKLAND, Calif.–(BUSINESS WIRE)–Eko, a digital health company building AI-powered screening and telehealth solutions to fight cardiovascular disease, today announced that the U.S. Food and Drug Administration […]

Affera’s Technology for Cardiac Arrhythmia Treatment Highlighted at the 2020 Heart Rhythm Society Late-Breaking Clinical Trial Session and Three Simultaneous Publications

WATERTOWN, Mass., May 12, 2020 /PRNewswire/ — Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today that its platform was featured prominently in scientific sessions at the Heart Rhythm Society 2020 (HRS) meeting held online May 6-9.  Simultaneously, three manuscripts describing pre-clinical experiments and clinical trials […]

CardioFocus Announces US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation

MARLBOROUGH, Mass., May 12, 2020 /PRNewswire/ — CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the next-generation HeartLight® X3 Endoscopic Ablation System for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Approval of the HeartLight X3 System came as a result of a comprehensive submission, including outcomes […]

Last patient included in Acarix’s exploratory heart failure study SEISMO

Malmö, Sweden May 11, 2020 Last patient included in Acarix’s exploratory heart failure study SEISMO Acarix AB (publ) today announced that the last patient has been included in the exploratory SEISMO study on a potential heart failure application. The exploratory clinical heart failure trial SEISMO was initiated in June 2018 to evaluate the possibility […]

FARAPULSE’s Pioneering Clinical Results Link Compelling Long-term Outcomes to Established Safety and Lesion Durability Data

MENLO PARK, CA, May 7, 2020 /PRNewswire/ – FARAPULSE Inc. (“FARAPULSE” or “the Company”) and its pulsed field ablation (PFA) technology for Atrial Fibrillation featured heavily in the collection of science published online by the Heart Rhythm Society in lieu of an annual meeting. Highlights of the data presented by the investigators from seven […]