For those of us who haven't been fortunate enough to see the Pulse in action ( just a few sour grapes ***grin *** ), I took this screen shot from the video ( sorry about the clarity ). The data is presented in an easy to understand format, with reference to the Conneqt App ( which already has clearance ) for further information to interpret the results.
Information like " Hypertension Stage 2 in red " and CBP " Average" in green
With the new OTC Hearing Aid category, consumers purchase the device, take it home, then use the device in conjunction with the app to adjust to their specific needs. That is, the FDA clearly now has a precedent & accepts devices/apps working together as an OTC mechanism.
All told, I can see why this is taking longer than expected, but given we have been advised the process is still moving in a positive direction , with a positive outcome expected ... we should remain positive.
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