FDA provides clearance to market predictive analytic technology developed at U-M Weil Institute
The release of Michigan Medicine spin-off company Fifth Eye’s medical device software system marks the second analytic to gain access to the US market in the past year.
Contact:
Megan VanStratt, Marketing Director, MCIRCC
vanstrat@umich.edu
(248) 912-7271
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ANN ARBOR, MI –The U.S. Food and Drug Administration (FDA) has provided 510k clearance to market Michigan Medicine device spin-off company Fifth Eye, Inc.’s clinical support software, the AHI System™, to hospitals across the United States.
The AHI System is an artificial intelligence software medical device that includes two patented analytics. The 510k clearance comes less than a year following the FDA’s De Novo classification of Fifth Eye’s first analytic, the Analytic for Hemodynamic Instability (AHI), which detects insufficient blood flow to vital organs in real-time from information embedded in an ECG signal alone. The release of the second generation brings enhancements to AHI, including a new analytic, the AHI Predictive Index (AHI-PI), which can automatically and continuously predict the likelihood of future episodes of hemodynamic instability earlier than is possible with vital signs. Both analytics were based on technologies developed and tested over four years at the Max Harry Weil Institute for Critical Care Research and Innovation at U-M and licensed by Fifth Eye.
Fifth Eye CEO Jen Baird collaborated with the Weil Institute team for more than nine months before licensing AHI and forming Fifth Eye in 2018. Since then, the two have continued to work together to support clinical research and gathering of data for clinical impact required for the FDA’s evaluation. In March 2021, AHI was granted De Novo classification from the FDA to begin commercialization of the device.
“The Weil Institute has been instrumental in developing the analytic, demonstrating its clinical potential, as well as supporting the formation of the startup and facilitating research to support our FDA submissions,” said Baird. “We’re very excited for this recent milestone and the future of the AHI System as we begin hospital deployments at pilot sites across the US.”
In the initial FDA-reviewed clinical study, AHI identified hemodynamic instability with 96% sensitivity and 85% specificity compared to a traditional vital signs-based reference standard. In the most recent study, AHI-PI significantly differentiated critical care patients' likelihood of developing hemodynamic instability. Patients with high-risk indicators were 51x more likely than those with low-risk indicators to have an episode of hemodynamic instability in the next hour. Additionally, AHI-PI high-risk indicators predicted 89% of first episodes of hemodynamic instability with a median lead-time of 48 minutes ahead of continuous arterial line blood pressure and heart rate vital signs.
"AHI is a game changer for hospitals and staff that are being stretched to their limits with over-crowded emergency rooms and ICUs."
Jen Baird
CEO, Fifth Eye, Inc.
“This partnership is a prime example of the Weil Institute’s strategy of transforming critical care through innovation, integration, and entrepreneurship by lowering the barriers to team science, said Kevin Ward, executive director of the Weil Institute and a professor of emergency medicine at U-M. “The technology was a faculty collaboration across the fields of medicine, engineering and mathematics, made possible through the Weil Institute’s unique core infrastructure.”
Clinicians can access AHI through any browser-enabled device, including a mobile phone or tablet. And since data is automatically collected and updated every two minutes, AHI reduces the surveillance burden on the nursing staff while providing access to new and valuable information to help them confidently prioritize their time.
“Using hemodynamic instability as a marker, AHI is a game changer for hospitals and staff that are being stretched to their limits with over-crowded emergency rooms and ICUs,” said Baird. "The AHI System provides physicians and nurses current, clinically validated insights regarding which patients may require additional vigilance to avoid an impending crisis. Conversely, AHI can bring the confidence of objective information to support the timely discharge or transfer of patients to lower acute settings, freeing up precious resources for additional patients."
“The vision of AHI was born out of our continued inability to predict when patients would become unstable, especially in settings where they cannot be intensively monitored,” said Ward. “Having the ability to be alerted before an event occurs, gives us precious time to intervene and prevent patient deterioration before it occurs. The implication of such a technology is that it has the potential to save lives not only in the hospital but also at home, in the ambulance, and on the battlefield.”
Disclosure: Kevin Ward, M.D., has an ownership interest in Fifth Eye Inc.
About Fifth Eye Inc.
Fifth Eye Inc. is an Ann Arbor, Michigan-based company that develops intuitive, real-time clinical analytics based on physiologic waveforms to improve outcomes and reduce costs. Fifth Eye's machine-learning technology is licensed from the University of Michigan. The AHI System™ is FDA cleared, clinical decision support software that monitors hospital patients and continuously predicts the risk of hemodynamic instability earlier than is possible with vital signs. The AHI System requires only the information embedded in an ECG signal. For more information, please visit www.fiftheye.com.
About the Weil Institute, formerly MCIRCC
The team at the Max Harry Weil Institute for Critical Care Research and Innovation (formerly the Michigan Center for Integrative Research in Critical Care) is dedicated to pushing the leading edge of research to develop new technologies and novel therapies for the most critically ill and injured patients. Through a unique formula of innovation, integration and entrepreneurship that was first imagined by Weil, their multi-disciplinary teams of health providers, basic scientists, engineers, data scientists, commercialization coaches, donors and industry partners are taking a boundless approach to re-imagining every aspect of critical care medicine. For more information, visit weilinstitute.med.umich.edu.