Vital Connect HealthPatch MD Biosensor Receives FDA Clearance
July 7, 2014 — Vital Connect announced its HealthPatch MD biosensor has received U.S. Food and Drug Administration (FDA) clearance. The solution is capable of capturing clinical-grade biometric measurements and is the first FDA-cleared medical device that includes a fall detection feature. Designed to support the treatment of a range of diseases and conditions, the HealthPatch MD 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.
Combined with Vital Connect’s proprietary algorithms, the sensor’s technologies enable the device to provide clinical-grade measurements of the following core health metrics: single-lead ECG (electrocardiogram), 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.
“We are very proud and excited that the HealthPatch MD has received FDA clearance and can now be sold in the United States for medical use,” said Vital Connect CEO Nersi Nazari. “Together with our partners, we cannot wait to begin implementing solutions using the HealthPatch MD to optimize the way healthcare is delivered in the U.S.”
Healthcare professionals will be able to use the sensor 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 received regulatory approval (CE mark) for distribution in the European Union, and is licensed and registered by Health Canada for distribution in Canada.
For more information: www.vitalconnect.com