From vision to mass production

Conventional ambulatory ECG monitors, while accurate, offer a poor wearability experience as they rely on the use of wires and/or patches. New wearable technologies, implementing wireless electrode systems, have improved wearability, increasing patient satisfaction, but not yet resolved the problem.
How to go from vision to FDA 510k-cleared for a novel non-invasive, patchless, wireless Holter monitor (QardioCore, by Qardio, Inc.).

A Presentation by Rosario Iannella, Founder and CTO at Qardio, Inc.

About Rosario Iannella
20+ years in technology and product design for wearable sensors, machine learning, advanced software components.
10 years inventing, designing and developing products at Qardio.
MSc in Electronic Engineering, Italy

About Qardio, Inc
Qardio designs innovative health monitoring devices that fit the modern lifestyle. Our clinically validated, award-winning devices are smart and powerful so you can take charge of what matters most: your health.

Qardio’s first product, QardioArm, is a wireless blood pressure monitor that connects with Apple’s Health app; it received FDA 510(k) clearance in June 2014.
At CES 2015, Qardio announced two new products, QardioBase, a smart scale and body analyzer, and QardioMD, a medical dashboard for doctors.[4] QardioBase became available for sale in November 2015.
Qardio launched the second generation of its smart scale, Qardio Base 2, in September 2017.
QardioCore ambulatory ECG/EKG monitor received CE marking in August 2017.
Qardio was selected as “Small Business of the Year” at the 2018 Entrepreneur Awards by Consumer Tech Association.
QardioCore ambulatory ECG/EKG monitor received FDA 510(k) clearance in February 2021.

Rosario Iannella is speaker at the 2022 edition of the Health Tech Event, Innovation meets Regulation with the presentation title: From vision to mass production.

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