Press
2023
Informed Vital Core Clinical Study
May 15, 2023
Mindset Medical is pleased to announce the kick-off of our first clinical study (ref NCT05853380) to support FDA approval of our vital signs product, Informed Vital Core. This study is designed to evaluate the accuracy of a web-based application (Software as a Medical Device) designed for measurements of vital signs including pulse rate (PR). Pulse rate measurement will be collected, calculated, and displayed on the application. A conventional ECG device will also be used to collect and display the pulse rate at the same time. If additional consent is obtained subjects may provide blood pressure and SpO2 measurements for the web-based application.
Additional information and detail is provided on the attached link:
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