FDA grants De Novo classification for innovative analytic technology developed at MCIRCC
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Contact:
Megan VanStratt, Marketing Director, MCIRCC
vanstrat@umich.edu
(248) 912-7271
ANN ARBOR, MI – The U.S. Food and Drug Administration (FDA) has granted De Novo classification to Michigan Medicine medical device software spin-off company Fifth Eye’s first product, the Analytic for Hemodynamic Instability (AHI).
Based on technologies developed over four years at the University of Michigan Center for Integrative Research in Critical Care (MCIRCC), AHI uses advanced signal processing and machine learning of continuous single lead electrocardiogram monitoring to identify at risk patients based on emerging signs of hemodynamic instability – a leading cause of death for critically ill or injured patients. AHI is the first device to provide non-invasive, continuous and reliable monitoring of hemodynamic status. In an FDA-reviewed clinical study, AHI identified hemodynamic instability with 96% sensitivity and 85% specificity compared to a traditional vital signs-based reference standard.
“The current approach to monitoring hemodynamic instability is intermittent, resource intensive, and error prone,” said Jen Baird, CEO of Fifth Eye and U-M alum. “Using hemodynamic instability as a marker, AHI is a game changer in the fight to quickly identify unexpected patient deterioration due to undetected internal bleeding, sepsis, COVID-19 complications, and other critical conditions. It can allow clinicians to better prioritize at-risk patients and intervene sooner. AHI fills in the blind spots between intermittent vital sign measurements with no additional nurse burden. By distinguishing at-risk and stable patients more easily, hospitals can ensure the right resources – beds, clinical teams, PPE – are used to improve patient care.”
The De Novo grant recognizes the unique nature of AHI while confirming it is both safe and effective. As a result, Fifth Eye can now begin commercialization and marketing of AHI to hospitals throughout the United States.
The technology has come a long way in the four years since Baird first reached out to the University’s Innovation Partnerships unit to find new and innovative ideas to take into the marketplace. Upon meeting and collaborating with the MCIRCC team for nine months, she licensed two of MCIRCC’s innovative machine-learning trained analytics, including AHI.
“This is a very important innovation in critical care medicine that could span and scale from the ICU to hospital wards to home care and even the battlefield,” said Dr. Kevin Ward, Professor of Emergency Medicine and executive director of MCIRCC. “The path that AHI has taken from idea conception to multidisciplinary team science-based translational research to licensing, and now FDA-granted classification is exactly what MCIRCC aims to do as organization – transforming critical care through innovation, integration, and entrepreneurship to deliver novel life-saving solutions to patients.” Dr. Ward is one of the inventors of AHI and has a small ownership interest in the Fifth Eye.
Baird thanked the numerous people and groups that have supported the development of AHI.
“We are super excited to have reached this milestone,” she said. “At Fifth Eye, we view our relationship with MCIRCC and Michigan Medicine as an ongoing collaboration. Future research is in the planning stages and we will continue to innovate together.”
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. Born in a hospital and taught by clinicians, Fifth Eye’s licensed technology from the University of Michigan has FDA De Novo authorization for in-hospital, continuous monitoring of patient clinical trajectory. The University is a partial-owner of Fifth Eye and entitled to royalties from sales of AHI. For more information, please visit www.fiftheye.com.
About MCIRCC
The team at the Michigan Center for Integrative Research in Critical Care (MCIRCC) 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, their multi-disciplinary teams of health providers, basic scientists, engineers, and data scientists, commercialization coaches, donors and industry partners are taking a boundless approach on re-imagining every aspect of critical care medicine. For more information, visit www.mcircc.umich.edu.
About Innovation Partnerships
Serving the University of Michigan community of innovators on all 3 campuses, including U-M Ann Arbor, U-M Dearborn, and U-M Flint, U-M Innovation Partnerships is responsible for commercializing research discoveries and reports to the U-M Office of Research. We enhance these research discoveries to encourage licensing and broad deployment with existing businesses and newly-formed U-M start-ups. U-M Innovation Partnerships has earned a reputation for performance among the top 10 of all universities.