View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
June 10, 2022

US FDA approves Medicalgorithmics’ Qpatch ECG monitoring device

The device includes an eInk screen that allows physicians and patients to interact with the wearable.

The US Food and Drug Administration (FDA) has approved Medicalgorithmics’ ECG wearable unit, Qpatch.

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

The new ECG wearable device has been designed to measure individual ECG signals and obtain accurate cardiac arrhythmia diagnoses from monitoring sessions of up to 15 days.

It features an eInk screen that allows physicians and patients to interact with the wearable.

Qpatch also provides real-time ECG readings that can be observed through near-field communication on a smartphone.

This allows ongoing quality control of the recorded ECG signal.

Medicalgorithmics board member Jarosław Jerzakowski said: “Securing the FDA approval for Qpatch is a major milestone celebrating the intensive effort that we have put into this project.

“Thanks to Qpatch our offer is now comprehensive. ECG diagnostics using wearables is very popular in the US and a method desired by both physicians and users.

“The FDA approval is a green light for us to prepare Qpatch’s market entry in the United States. We also want to pursue foreign markets as quickly as possible in regions where we have already been developing our sales.”

The company stated that the new device is waterproof, can be used with standard inexpensive electrodes and has a low weight for convenience.

It also noted that the Qpatch ECG monitoring device has been selected for a clinical trial that will be conducted by leading research centres in the Cardiac Surgery Research Network (CTSN).

The National Institutes of Health (NIH) and National Heart, Lung and Blood Institute (NHLBI) will provide funds for the trial.

Related Companies

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network