A medical device that works to detect if a patient will become unstable earlier than traditional vital signs received the green light to be marketed to U.S. hospitals.

Fifth Eye Inc., 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 identify signs of 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 catch early signs of patient instability several hours before traditional methods of collecting vital signs.

“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. “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.”

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

“AHI fills in the blind spots with no additional nurse burden,” Baird said. “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 FDA’s De Novo classification process assesses risk, and AHI is considered safe and effective for achieving it. The product will also serve as a model for similar devices created in the future.

Before being developed at Michigan Medicine, the concept behind AHI originated from a simulated study on hypovolemia (hemorrhage) by the U.S. Army. The researchers at MCIRCC then created a unique computer algorithm that takes data from a continuous ECG signal to identify hemodynamic decline.

Fifth Eye licensed the product with help from U-M Tech Transfer. The company received an $11.5 million Series A investment to develop and commercialize AHI.

“This is a very important innovation in critical care medicine that could span and scale from the ICU to home care and even the battlefield,” said Kevin Ward, M.D., a co-inventor of the technology and executive director of MCIRCC. “The path that AHI has taken from idea conception to FDA-granted classification is exactly what MCIRCC aims to do as an organization – transform critical care through innovation, integration and entrepreneurship to deliver novel, life-saving solutions to patients.”

Disclosure: Kevin Ward, M.D., has an ownership interest in Fifth Eye Inc.