CorSense Accuracy and Validation

The CorSense has been internally validated with accuracy equivalent to a 5-lead ECG/EKG, the gold standard for HRV detection, with less than 3% variation across multiple subjects with differing skin tones.

We are not able to share more details on these proprietary internal results, but 3rd party validation is underway to support the findings. Validation of the device can be done by comparing to a chest strap or a manually calculated HRV reading - here is an example (done on a competing app): https://www.hrv4training.com/blog/corsense

If you would like to check it out, this paper discusses how HRV can be used and how to use the raw output: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6090397/

The CorSense is FCC, CE and IC certified. The certificate numbers are:

1. FCC is LCS180105015AE

2. CE is LCS180105017AE

3. IC is 23646-E1

FDA clearance is not required as a consumer general wellness and fitness sensor, as outlined here and applied towards other similar products (Apple Watch, etc): https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-general-wellness-policy-low-risk-devices-september-1-2016

More info here: Data From CorSense