Qardio receives 510(k) approval for a new device, QardioCore


Popular digital cardiology company Qardio received 510(k) approval for a brand new product called the QardioCore.

The maker of popular digital health products such as the QardioArm blood pressure equipment and QardioBase 2, the digital smart scale has been actively engaged in positioning itself in the remote health monitoring area via its QMD platform.


The QardioCore product is a cardiovascular monitoring device that serves as a medical magnetic tape recorder. The new product was approved under section 870.2800.

Qardio Qardiocore

Details of this new Qardio product are unclear at the moment.

According to the filing, the company had submitted its pre-market approval application on 06/17/2020, and the decision date was 02/28/2021.

The chances are that this new product is being positioned more for the remote monitoring area than a consumer-grade digital health device.

The majority of the initiatives that Qardio launched or announced in 2020 have been focused on remote health monitoring.

The company had tied up with OBS Medical last year in advancing a remote monitoring solution, QardioMD+VSI, that combines the data from Qardio’s medically accurate wearables with the Visensia® predictive algorithm. This combination allows clinicians to remotely review a patients’ vital signs in real-time and prioritize them according to the Visensia risk stratification algorithm.

Other 2020 strategic partnerships include the one with neoHealthTech to provide remote monitoring capabilities to NHS in the UK.

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Sudz Niel Kar
I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox. In my day job, I advise Fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health and fitness-tech evolution and keeping a close eye on patents, FDA approvals, strategic partnerships, and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch Ultra or Samsung Galaxy Watch and closely monitor my HRV and other recovery metrics.


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