Predictive patient stability technology gets FDA market approval

March 24, 2021

A medical device that predicts if a patient will become unstable earlier than traditional vital signs  received the green light to be marketed to U.S. hospitals, according to a news release from Michigan Medicine.

Fifth Eye, a Michigan Medicine spinoff medical device software company founded in 2017, was recently granted FDA De Novo classification for its Analytic for Hemodynamic Instability (AHI). The noninvasive device continuously monitors electrocardiogram (ECG) signals to predict hemodynamic decline.

Technology driving AHI was developed at the University of Michigan Center for Integrative Research in Critical Care (MCIRCC). Researchers, some of whom would go on to form Fifth Eye, designed the device to detect early signs of patient instability several hours before traditional methods of collecting vital signs.

Hemodynamic instability is a leading cause of death for critically ill or injured patients. AHI updates a patient’s risk every two minutes, allowing clinicians to intervene before a condition worsens.

In an clinical study, AHI identified hemodynamic instability with 96 percent sensitivity and 85 percent specificity compared to traditional vital signs-based reference standards.

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