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Research

Photo for Vitaliti Verification

Vitaliti Verification

Official Title

Vitaliti Verification

Status

Ongoing

Overview

Cloud-DX Vitaliti™ is a groundbreaking new low profile automated vital sign monitor which includes a continuous non-invasive blood pressure measurement system, 2-Lead ECG (sampled at 500 Hz), heart rate and heart rate variability, respiration rate, temperature (infrared sensor in ear sampled at 20 Hz), blood oxygen saturation (Red, IR, and Green channels sampled at 200 Hz), and pulse wave velocity. Cloud-DX Vitaliti™ has undergone preliminary testing and is now ready for clinical verification testing to achieve compliance with the Institute of Electrical and Electronics Engineers (IEEE) and the American Safety in Medical Technology (AAMI- ISO) standards of medical grade device.

Study Design

Multi-centre, blinded, randomized controlled trial

Primary Endpoint

Electrical and Electronics Engineers (IEEE) and the American Safety in Medical Technology (AAMI-ISO)

Number of Patients

50

Number of Sites

1

Number of Countries

1

Study Period

2017-2018

Principal Investigator

Michael McGillion, PJ Devereaux

Program Manager

Shirley Pettit

Research Coordinator

Prathiba Harsha

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