Electrocardiography

Qardio Announces FDA Clearance for QardioCore, a self-fit continuous ambulatory ECG to view and annotate ECG

Retrieved on: 
Thursday, March 11, 2021

SAN FRANCISCO, March 11, 2021 /PRNewswire/ -- Qardio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510k clearance for its QardioCore ambulatory ECG device.

Key Points: 
  • SAN FRANCISCO, March 11, 2021 /PRNewswire/ -- Qardio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510k clearance for its QardioCore ambulatory ECG device.
  • QardioCore will initially be marketed for holter monitoring applications, for use with QardioMD, Qardio's cloud-based remote patient monitoring solution.
  • Qardio co-founder Rosario Iannella commented "Our goal for QardioCore has always been to create a better experience for patients and care providers.
  • Qardio CEO Mark Prince added "Our initial ECG service has been designed for remote deployment and works right out of the box.

Qardio Announces FDA Clearance for QardioCore, a self-fit continuous ambulatory ECG to view and annotate ECG

Retrieved on: 
Thursday, March 11, 2021

SAN FRANCISCO, March 11, 2021 /PRNewswire/ -- Qardio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510k clearance for its QardioCore ambulatory ECG device.

Key Points: 
  • SAN FRANCISCO, March 11, 2021 /PRNewswire/ -- Qardio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510k clearance for its QardioCore ambulatory ECG device.
  • QardioCore will initially be marketed for holter monitoring applications, for use with QardioMD, Qardio's cloud-based remote patient monitoring solution.
  • Qardio co-founder Rosario Iannella commented "Our goal for QardioCore has always been to create a better experience for patients and care providers.
  • Qardio CEO Mark Prince added "Our initial ECG service has been designed for remote deployment and works right out of the box.

AliveCor Announces Collaboration with AstraZeneca to Develop Non-Invasive Potassium Monitoring Solutions

Retrieved on: 
Tuesday, February 16, 2021

The collaboration will translate AliveCor's potassium detection technology and science, which enables potassium measurement outside of blood draws, into real-world disease management applications and solutions.

Key Points: 
  • The collaboration will translate AliveCor's potassium detection technology and science, which enables potassium measurement outside of blood draws, into real-world disease management applications and solutions.
  • Kardia-K is being built using AliveCor's proprietary deep neural network, and analyzes electrocardiograms (ECGs) to measure a patient's potassium levels without requiring any blood from the patient.
  • AliveCor's neural network was trained in collaboration with Mayo Clinic using more than 1.5 million ECGs and was validated on approximately 62,000 ECGs.
  • "Our collaboration with AstraZeneca exemplifies how pharmaceutical and digital health companies can work together to drive the future of medicine."

VivaLNK Offers Untethered Wearable ECG Monitor Solution for Six-Minute Walk Test

Retrieved on: 
Tuesday, February 16, 2021

CAMPBELL, Calif., Feb. 16, 2021 /PRNewswire/ -- VivaLNK , a leading provider of connected healthcare solutions, announces availability of a wearable ECG monitoring solution designed to wirelessly capture ECG and heart rate during a six-minute walk test (6MWT).

Key Points: 
  • CAMPBELL, Calif., Feb. 16, 2021 /PRNewswire/ -- VivaLNK , a leading provider of connected healthcare solutions, announces availability of a wearable ECG monitoring solution designed to wirelessly capture ECG and heart rate during a six-minute walk test (6MWT).
  • It involves monitoring a patient while they walk as far as they can in a six-minute period and assessing cardiopulmonary function.
  • In these studies, patients wear the wireless ECG patch while a clinician is able to monitor and control the test using a mobile app.
  • At only 7.5 grams, VivaLNK's unique wearable ECG monitor is barely noticeable when worn.

MicroPort CRM Launches MicroPort Academy CRM, an Education Website Dedicated to Healthcare Professionals and Designed by Experts in Cardiac Pacing

Retrieved on: 
Tuesday, February 16, 2021

MicroPort CRM, a subsidiary of MicroPort Scientific Corporation (Stock code: 00853.HK), a pioneering company in the field of Cardiac Rhythm Management, has launched an online education website, MicroPort Academy CRM.

Key Points: 
  • MicroPort CRM, a subsidiary of MicroPort Scientific Corporation (Stock code: 00853.HK), a pioneering company in the field of Cardiac Rhythm Management, has launched an online education website, MicroPort Academy CRM.
  • The website is dedicated to Healthcare Professionals who want to enhance their knowledge about cardiac pacing therapy and the functionality of MicroPort CRM products.
  • MicroPort Academy CRM provides personalized and interactive training plans, ranging from diagnosis of ECG tracings to techniques of pacemaker implantation, programming simulation and troubleshooting.
  • I have no doubt that MicroPort Academy CRM brings a unique experience for cardiac pacing online training.

New Study Published in JACC Clinical EP Validates that Cardiologs' AI Eliminates Nearly Two-Thirds of False Positives in Remote Monitoring for Atrial Fibrillation

Retrieved on: 
Wednesday, February 10, 2021

The findings show that Cardiologs' AI-based ECG analysis solution significantly reduces the rate of false positive atrial fibrillation (AFib) detection in remote cardiac monitoring of patients with implantable loop recorders (ILRs).

Key Points: 
  • The findings show that Cardiologs' AI-based ECG analysis solution significantly reduces the rate of false positive atrial fibrillation (AFib) detection in remote cardiac monitoring of patients with implantable loop recorders (ILRs).
  • Cardiologs and Valley Health tracked a cohort of 425 patients who received an ILR for known AFib or cryptogenic stroke.
  • Since ILRs transmit data daily, these false positives are one of the Achilles heels of remote cardiac monitoring.
  • Publication of our successful trial results in JACC EP further validates the considerable promise of our solution for the clinical community.

CardiacSense Medical Grade Watch receives CE Mark for continuous detection of Atrial Fibrillation

Retrieved on: 
Wednesday, February 10, 2021

The indications certified include "detection of Atrial Fibrillation (A-Fib)" and "monitoring of Heart Rate Variability (HRV)" with continuous Photoplethysmography (PPG) and spot Electrocardiogram (ECG).

Key Points: 
  • The indications certified include "detection of Atrial Fibrillation (A-Fib)" and "monitoring of Heart Rate Variability (HRV)" with continuous Photoplethysmography (PPG) and spot Electrocardiogram (ECG).
  • CardiacSense's medical watch CE Mark enables continuous, long-term, accurate and comfortable patient monitoring without the need to implant invasive cardiac monitors - a prevalent practice for patients experiencing arrhythmias.
  • Data from 2 clinical trials reviewed for the CE Mark demonstrated accurate detection of A-Fib by continuous PPG of over 99%.
  • The certification will enable commercialize of the medical watch in the EU and other CE Mark approved countries.

CardiacSense Medical Grade Watch receives CE Mark for continuous detection of Atrial Fibrillation

Retrieved on: 
Wednesday, February 10, 2021

The indications certified include "detection of Atrial Fibrillation (A-Fib)" and "monitoring of Heart Rate Variability (HRV)" with continuous Photoplethysmography (PPG) and spot Electrocardiogram (ECG).

Key Points: 
  • The indications certified include "detection of Atrial Fibrillation (A-Fib)" and "monitoring of Heart Rate Variability (HRV)" with continuous Photoplethysmography (PPG) and spot Electrocardiogram (ECG).
  • CardiacSense's medical watch CE Mark enables continuous, long-term, accurate and comfortable patient monitoring without the need to implant invasive cardiac monitors - a prevalent practice for patients experiencing arrhythmias.
  • Data from 2 clinical trials reviewed for the CE Mark demonstrated accurate detection of A-Fib by continuous PPG of over 99%.
  • The certification will enable commercialize of the medical watch in the EU and other CE Mark approved countries.

B-Secur Receives FDA Regulatory Clearance For Its HeartKey® EKG/ECG Technology

Retrieved on: 
Thursday, February 4, 2021

B-Secur , a leader in EKG/ECG technology, today announced that it has received U.S. Food and Drug Administration (FDA) 510(K) clearance of its HeartKey software library1.

Key Points: 
  • B-Secur , a leader in EKG/ECG technology, today announced that it has received U.S. Food and Drug Administration (FDA) 510(K) clearance of its HeartKey software library1.
  • This clearance should significantly aid our partners and customers increase the speed to market for their technology.
  • FDA clearance has been granted for the following EKG/ECG feature algorithms: Signal Conditioning, Heart Rate and Arrhythmia Analysis.
  • FDA clearance of the HeartKey software library ensures B-Secur customers and partners can have confidence in its world-leading algorithm performance and accuracy.

New Wearable ECG Recorder Gets FDA Clearance: Versatile Wearable Sensor offers Extended Ambulatory ECG Recording Up to 21 Days

Retrieved on: 
Wednesday, February 3, 2021

MANLIUS, N.Y., Feb. 3, 2021 /PRNewswire-PRWeb/ -- Global Instrumentation, LLC, announced today the FDA has cleared the company's ultra-small wearable electrocardiogram (ECG) sensor, the M5 Recorder.

Key Points: 
  • MANLIUS, N.Y., Feb. 3, 2021 /PRNewswire-PRWeb/ -- Global Instrumentation, LLC, announced today the FDA has cleared the company's ultra-small wearable electrocardiogram (ECG) sensor, the M5 Recorder.
  • The device offers research organizations and physicians a reliable, shower-proof, and patient-friendly ECG sensor for precise long-term ECG data collection in the patient's home and ambulatory environments.
  • The M5 Recorder is water-resistant and weighs only 26 grams yet can store up to 21 days of 3-channel ECG recordings.
  • Through our proven research, design, and innovation capabilities, we partner closely with our customers to help enable the delivery of better healthcare.