Ann Arbor firm gets FDA nod for new medical tool to predict patient ‘crash’

ANN ARBOR—The Ann Arbor clinical analytics startup Fifth Eye Inc. announced that the U.S. Food and Drug Administration has granted its “de novo” classification to Fifth Eye’s Analytic for Hemodynamic Instability (AHI).

According to the FDA’s website, “De novo” classification means FDA officials believe the new software has “reasonable assurance of safety and effectiveness for the intended use.”

Fifth Eye’s AHI uses data from electrocardiograms to monitor patients for hemodynamic instability, a leading cause of death for critically ill or injured patients. AHI enables hemodynamic assessments every two minutes as opposed to every two hours or more, increasing the likelihood of timely patient rescue.

Fifth Eye’s machine learning-based software device, developed in collaboration with clinicians at the University of Michigan, gives nurses and doctors a real-time view into patients’ hemodynamic status. AHI automatically provides intuitive, time-trended updates without requiring vital sign assessment, manual data input in electronic health records, or score calculation.

AHI gives a reliable heads-up about emerging signs of hemodynamic instability, enabling proactive patient rescue.

“The current approach to monitoring hemodynamic instability is intermittent, resource intensive, and error prone,” said Jen Baird, CEO, Fifth Eye. “AHI is an easy-to-implement device that reduces nurse burden by giving a reliable heads-up about emerging signs of hemodynamic instability that can go undetected with ECG or vital signs alone, enabling proactive patient rescue.”

In an FDA-reviewed clinical study, AHI’s unstable classifications were highly correlated with hemodynamic instability, defined as hypotension (low blood pressure) plus tachycardia (extremely rapid heartbeat). AHI identified hemodynamic instability with 96 percent sensitivity and identified stable patients with 85 percent specificity compared to traditional vital signs-based reference standards. The results are from over 28,000 AHI outputs across 222 adult critical care patients.

“The problem of predicting unexpected patient decompensation remains critical for hospitals,” said Benjamin Bassin, M.D., Director, Emergency Critical Care Center, Michigan Medicine. “AHI provides reliable, noninvasive, and continuous monitoring of hemodynamic decompensation by way of ECG waveform analysis—as opposed to intermittent static vital signs—to identify at-risk patients across hospital settings, including remotely. This allows for much earlier intervention and has the potential to improve confidence, quality, safety and appropriate resource allocation across the spectra of U.S. healthcare systems.”

The AHI software is intended for use by healthcare professionals managing in-hospital patients 18 years or older who are receiving continuous physiological monitoring with an ECG.

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