Vital Connect HealthPatch MD Biosensor Receives FDA Clearance

Vital Connect (San Jose, CA), offering wearable biosensor technology, announced that its HealthPatch MD biosensor has received FDA clearance. The HealthPatch MD is capable of capturing clinical-grade biometric measurements and is the first FDA-cleared medical device that includes a fall detection feature. The HealthPatch MD, designed to support the treatment of a range of diseases and conditions, is a versatile and comprehensive biosensor solution that may be used by healthcare professionals to provide 24-hour, real-time, unattended monitoring of patients’ physiological data or vital signs.

Encapsulated within the HealthPatch MD are cutting-edge sensor and electronics technologies. Combined with Vital Connect’s proprietary algorithms, these technologies enable the device to provide clinical-grade measurements of the following core health metrics: single-lead electrocardiogram (ECG), heart rate, heart rate variability, respiratory rate, skin temperature, posture including fall detection and severity, and steps. The HealthPatch MD leverages on-board intelligence to perform sophisticated, proprietary SensorFusion algorithms, which process thousands of data points per minute to produce accurate robust measurements. 

Healthcare professionals will be able to use the HealthPatch MD to collect patient data on-demand and may be notified when physiological data falls outside selected parameters. The HealthPatch MD is intended to be less obtrusive than other sensors, can be customized for data reporting, operates on Bluetooth 4.0 and provides HIPPA-compliant cloud-based storage and connectivity.

The HealthPatch MD has also received regulatory approval (CE Mark) for distribution in the EU, and is licensed and registered by Health Canada for distribution in Canada. 

For more information on the HealthPatch MD and to explore ways this new technology can be incorporated into various healthcare settings to transform the landscape of treatment delivery, visit www.vitalconnect.com. 

Note: The HealthPatch MD is the patch portion of VitalConnect Platform in the 510 (k) and Technical File.