Vital Connect announced that its biosensor platform that includes the HealthPatch MD has received FDA clearance.
The platform was designed to be used in healthcare settings for unattended surveillance of physiological data including heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (including fall detection). The data gathered by the HealthPatch MD is transmitted wirelessly to a central location where it is stored for analysis. The platform is fully configurable and has the capability of sending notifications to an authorized person when needed.
“Receiving FDA clearance for the Vital Connect platform is an important milestone in the future of the United States healthcare system,” said Vital Connect CEO Nersi Nazari. “We are very proud of this achievement and look forward to working with partners to develop new and impactful methods for integrating the Vital Connect platform into a variety of clinical health solutions.”
The VitalConnect Platform and HealthPatch MD have also received regulatory approval (CE Mark) for distribution in EU, and is licensed and registered by Health Canada for distribution in Canada.