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Vital Connect’s FDA-Cleared Wearable Biosensor Available for use in Clinical Trials

Vital Connect announced today that its FDA-cleared wearable biosensor, HealthPatch® MD, is now available for use in clinical trials in partnership with Medidata, a leading global provider of cloud-based solutions for clinical research in life sciences. HealthPatch® MD can be used with Medidata’s industry-leading technology platform (Medidata Clinical Cloud®) and its mobile app for patient-reported outcomes (Medidata Patient Cloud®) to further remote patient monitoring, which has the potential to make clinical trials more efficient.

When deployed with the Medidata Clinical Cloud, HealthPatch® MD comprehensively collects large volumes of objective data that is reliable, secure and analysis-ready. By providing continuous insight into patient health metrics in near-real time, the combined technologies can enable faster, more patient-centric clinical research, while ensuring compliance and data quality.

HealthPatch® MD was included in Medidata’s recently announced method development project, which tested the impact of mHealth and cloud-based technologies on patient engagement, data quality and operational efficiencies in clinical trials. During the project, Medidata’s cloud-based platform collected, managed and reported clinical research data, including continuous data from HealthPatch® MD.

“Breakthroughs in mobile health adoption within clinical trials can come from clear demonstrations of using mHealth technology in a compliant, effective and safe way,” said Glen de Vries, Medidata’s president. “We’re thrilled to be partnering with Vital Connect and working together to help make these breakthroughs possible, enhance patient engagement and, ultimately, accelerate the pace of innovation in drug development.”

Vital Connect CEO Nersi Nazari said: “Clinical trials are an essential part of the scientific process for developing new drug therapies and devices that can save lives and improve quality of life, and our partnership with Medidata is one more example of HealthPatch MD impacting the global healthcare market. The integration of the HealthPatch MD with the Medidata Clinical Cloud will streamline the process of monitoring clinical trial patients with the potential to reduce trial costs, minimize patient risk and generate new insights.”

The HealthPatch®MD, which weighs only 10g and is 6mm (0.24”) thick, is a disposable biosensor worn on the chest. Its light and thin form factor is comfortable for patients and less obtrusive than conventional monitoring equipment. Cutting-edge sensors and electronics, along with advanced algorithm technologies in HealthPatch® MD, provide continuous, clinical-grade measurements of ECG, respiratory rate, heart rate, heart rate variability, skin temperature, physical activity, posture, and fall detection. The HealthPatch® MD is cleared by the FDA, 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:

Note: The HealthPatch® MD is referred to as the VitalConnect Platform in the FDA 510(k) and Technical File.


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