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Jun 6th, 2014
Vital connect HealthPatch™ MD biosensor receives FDA clearance
Innovative platform enables healthcare providers to know more, know sooner and respond faster.
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Vital Connect, an industry pioneer of wearable biosensor technology, announced today that its HealthPatch™ MD biosensor has received FDA clearance. The HealthPatchTM 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 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.

“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 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 received regulatory approval (CE Mark) for distribution in 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: http://www.vitalconnect.com

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

About Vital Connect, Inc.
Vital Connect is a growing Silicon Valley-based company founded in 2011 with the goal to develop the newest generation of technologies that help address some of the most challenging healthcare issues in the world today. Vital Connect’s extensive expertise enables the company to create wireless, wearable biosensors that are small, powerful, and capable of capturing clinical-grade biometric measurements in a continuous, configurable and non-obtrusive manner. Through various partnerships, Vital Connect solutions will be available for use in hospitals, research facilities, doctor’s offices, care facilities and homes. For more information, visit: http://www.vitalconnect.com

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