One of the big themes that emerged from CES 2017 was the fact that wearable Health Tech products can not just spew out measurements without regard to their accuracy. “Clinical grade” data is now the table stakes in the wearables game, as more companies coming from the medical equipment markets are playing a bigger role in the Health Tech market. One of the indicators that companies are getting more serious about accuracy is that more are pursing FDA clearance for their products. This requires that they demonstrate that the devices produce results equivalent to already-approved medical devices.
For example, the new MOCACuff blood pressure meter from MOCACARE has received FDA clearance. The company has conducted extensive clinical studies with their device, comparing the results to standard devices used in hospitals. The device measures your blood pressure and heart rate, and displays the results on a large, easy-to-read display. It also uses a colored scale for the results, based on the American Heart Association’s (AHA) blood pressure categories.
The MOCACuff is also a smart device; one tap of a button sends the results via Bluetooth to a smartphone app for storage so you can compare measurements over time. You can also share the results with family members and healthcare professionals through a HIPAA-compliant connection. The rechargeable battery is good for about 200 measurements, and the app is available for both iOS and Android platforms.
