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.).

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