Rhythm

Anumana Receives U.S. FDA 510(k) Clearance for ECG-AI Algorithm to Detect Low Ejection Fraction

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anumana, Inc., a leading AI-driven health technology and nference portfolio company working in collaboration with Mayo Clinic, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for ECG-AI LEF, a breakthrough artificial intelligence (AI)-powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure. “Anumana’s […]

iRhythm Launches Next Generation Zio Monitor and Enhanced Zio Service: Its Smallest, Lightest and Thinnest Cardiac Monitor

SAN FRANCISCO, Sept. 26, 2023 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ:IRTC) today announced the U.S. launch of its next-generation Zio® monitor and enhanced Zio® long-term continuous monitoring (LTCM) service. Zio monitor is iRhythm’s smallest, lightest and thinnest cardiac monitor, enhancing the cardiac monitoring experience for patients and healthcare providers together with new service […]

Kestra Medical Technologies Offers Electrophysiology and Cardiology Clinicians Opportunity to Wear ASSURE WCD System at #HRX2023 Conference

SEATTLE–(BUSINESS WIRE)–Kestra Medical Technologies is launching the ASSURE Clinician Experience (ACE), a program that lets electrophysiology and cardiology professionals wear and simulate use of the ASSURE® Wearable Cardioverter Defibrillator (WCD) system at The Heart Rhythm Society #HRX2023 global health and technology conference, September 21-23, 2023 in Seattle, WA. Clinicians that participate will be […]

Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT™ for the Treatment of Hypertension in Pacemaker Patients

NEW HOPE, Pa., Sept. 19, 2023 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the U.S. Food and Drug Administration (“FDA”) granted approval of an investigational device exemption (“IDE”) to […]

Adagio Medical Announces Initiation and First Procedure in FULCRUM-VT Trial, Starting The Process For Bringing Ultra-Low Temperature Cryoablation for Ventricular Arrhythmias to US Market

LAGUNA HILLS, Calif., Sept. 14, 2023 /PRNewswire/ — Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced the first ultra-low temperature cryoablation (ULTC) procedure performed using the Adagio vCLAS™ catheter system in the United States as part of the FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation for Recurring Monomorphic Ventricular Tachycardia) clinical trial, NCT # […]

Implicity CEO Selected to Participate in HRX 2023 Panel Discussion on AI & Remote Cardiac Monitoring

CAMBRIDGE, Mass, Sept. 18, 2023 /PRNewswire/ — Implicity, a leader in remote patient monitoring (RPM) and cardiac data management solutions, announced today that co-founder and CEO Arnaud Rosier, MD, PhD, has been selected to participate in a panel discussion at the upcoming HRX 2023 Digital Health Event in Seattle, WA. The discussion, AI-aided Remote Interventions – Will […]

Field Medical, Inc. Announces Oversubscribed Seed Round to Advance Next-Generation Cardiac Ablation Technology

CARDIFF-BY-THE-SEA, Calif., Sept. 18, 2023 /PRNewswire/ — Field Medical, Inc. (Field Medical), an emerging leader in cardiac catheter ablation, announced today that it has closed its oversubscribed seed round with investments totaling $14M. The convertible note funding was led by private investors who were joined by multiple strategic investors. This financing will support preclinical-to-clinical […]

Atrial Fibrillation Study with Abelacimab Stopped Early by the Data Monitoring Committee Due to an Overwhelming Reduction in Bleeding as Compared to a DOAC (Direct Oral Anticoagulant)

CAMBRIDGE, Mass., September 18, 2023 (BUSINESS WIRE)– Anthos Therapeutics, Inc., a clinical stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences, announced today that the AZALEA-TIMI 71 Phase 2 study in 1,287 patients with atrial fibrillation at moderate-to-high risk of stroke, met its primary endpoint. The […]

SmartCardia Receives FDA Clearance for its 14-Day 7-Lead ECG Real-Time Patch and Cloud Platform

LAUSANNE, Switzerland, Sept. 15, 2023 /PRNewswire/ — SmartCardia has received FDA clearance for its 7-lead real-time ECG monitoring patch and cloud platform. SmartCardia’s 7L patch is easy-to-wear, cable-free, waterproof and can be used for continuous monitoring for up to 14 days. SmartCardia 7L Patch SmartCardia Cloud Dashboard “SmartCardia’s 7L patch and cloud platform […]

Vektor Medical Unveils Enhanced vMap Technology for Accurate, Non-invasive Mapping of Cardiac Arrhythmias

SAN DIEGO–(BUSINESS WIRE)–Vektor Medical, developer of the only technology to accurately map arrhythmias using just 12-lead ECG data, today announced the release of a series of software enhancements to its AI-based non-invasive solution, vMap. Designed to improve ablation outcomes and procedural efficiencies, the newly updated vMap software integrates additional automation […]