Rhythm

New FDA Guidance Allows Use of KardiaMobile 6L to Measure QTc in COVID-19 Patients

World’s only FDA-cleared six-lead personal ECG will be used by healthcare professionals to monitor QT duration in patients receiving medications that can cause potentially life threatening QT prolongation. MOUNTAIN VIEW, Calif., March 23, 2020 /PRNewswire/ — AliveCor, the leader in artificial intelligence (AI)-based, personal ECG technology, and provider of enterprise cardiology solutions, today […]

Impulse Dynamics Announces First Enrollment in Post-Approval Study of CCM Therapy Delivered by the Optimizer System

Post-Approval Study will evaluate real-world safety and efficacy evidence for breakthrough heart failure therapy MT. LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced the first enrollment in a post-approval study of its innovative CCM™ therapy delivered by the Optimizer® system. […]

Femtech Startup Bloomer Tech Raises Series Seed Round Led by Material Impact

The MIT-spinoff commercializing a clinical grade, heart monitoring “Smart Bra” for cardiovascular disease represents the first Femtech investment outside of the reproductive health and breast cancer space CAMBRIDGE, Mass.–(BUSINESS WIRE)–Health technology company Bloomer Tech (Bloomer) today announced that it has raised $3M in a Series Seed funding round. Material Impact, who […]

AltaThera Pharmaceuticals Announces FDA Approval for New Indications of Sotalol IV: A New and Faster Way to Initiate Sotalol Therapy for Atrial Fibrillation (AFib) Patients

– Sotalol IV is now approved for 1-day hospital outpatient initiation of AFib therapy and faster dose escalations for existing patients – New FDA-approved dosing, monitoring and evaluation shortens the hospital stay from 3 days to 1 day – The new initiation provides physicians with a faster and safe way […]

Stereotaxis Earns FDA Clearance and Announces U.S. Launch of Genesis Robotic Magnetic Navigation System

ST. LOUIS, March 06, 2020 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias, announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the Genesis RMN® System for the robotic navigation of magnetic ablation catheters to treat heart […]

BioSig Appoints John W. Osborn, Ph.D. as Consultant on Autonomic Neuromodulation

New research project to focus on development of technological solutions for sympathetic nervous system disease Westport, CT, March 04, 2020 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover […]

Masimo Announces FDA Clearance of Continuous RRp® Monitoring

IRVINE, Calif.–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) announced today that continuous RRp® (respiration rate from the photoplethysmograph) monitoring of adult and pediatric patients with Rad-97®, Radical-7®, and Radius-7® Pulse CO-Oximeters® has received FDA clearance. With this clearance, both continuous and spot-check RRp are now available in the US, supported in a variety of pulse oximetry sensors […]

HUYA Bioscience International® Announces the Successful Completion of Phase 1 Trial of HBI-3000

Phase 2 trial will test the unique multi-channel ion blocker in acute atrial fibrillation SAN DIEGO, Feb. 28, 2020 /PRNewswire/ — HUYA Bioscience International, the leader in accelerating global development of China’s pharmaceutical innovations, has presented the results of a Phase I study of HBI-3000, a novel drug for cardioversion of atrial fibrillation (AF). […]

MemorialCare Heart & Vascular Institute at Long Beach Medical Center – Only Southern California Site Participating in Atrial Fibrillation Clinical Trial, Enrolls First Successful Patient

LONG BEACH, Calif., Feb. 27, 2020 /PRNewswire/ — The MemorialCare Heart & Vascular Institute at Long Beach Medical Center is the only hospital in Southern California — and one of only four sites in all of California — participating in the Dual Epicardial and Endocardial Procedure clinical trial (DEEP). The trial is a prospective, multi-center, single-arm, investigational device […]