Advanced Sensor
Ensures Accurate
Measurements
In 2024, the United States Food & Drug Administration (FDA) granted 510(k) approval to Vyvo Technology for the fingertip sensor of the LifeWatch™ as a Medical Device Type II.
This sensor is identical to what is integrated into the bands of the BioSense™ Watch and BioSense health band.
The clearance is recognition that the sensor returns accurate and reliable measurements for blood oxygen (SpO2),vascular aging (APG), and blood pressure (BP).
The FDA found that the device was “substantially equivalent” to other devices, such as pulse oximeters.
