University of Chicago's AgileMD Receives FDA Approval, Moving Forward to Expanding Healthcare Technology

Published on Friday, June 28, 2024

AgileMD, a New Venture Challenge alumnus, was founded by a team from the University of Chicago Booth School of Business and the University of Chicago Medical Center.

AgileMD, founded by University of Chicago Booth Business School students and hospital physician-researchers, announced growing adoption of its AI-powered software and a significant step toward its mission to improve healthcare with technology.

The company's medical device software uses machine learning algorithms to continuously assess the condition of patients in hospitals, helping medical staff quickly identify those who need more advanced medical attention, and this week the company announced that its eCART Clinical Deterioration Suite has received 510(k) marketing clearance from the FDA.

The software is embedded directly into the electronic medical record and generates eCART scores and risk designations from approximately 100 real-time variables, including lab results, vital signs, nursing assessments, etc. Clinical staff are then guided through embedded clinical pathways to assess and manage care.

CEO Borna Safabakhsh, MBA 11

Speaking about the importance of FDA approval, Borna Safabakhsh (MBA ’11), co-founder and CEO of AgileMD, noted that the industry is focused on where and how the potential of AI in healthcare will be realized.

“There is a growing recognition that advanced models used in patient management need to be independently evaluated in real-world settings,” he explained. From our perspective, this approval represents a shift in that mindset.

The model was trained on about 1 million patient encounters across seven hospitals, and tested on about 2 million separate patient encounters across an additional 21 hospitals. These are huge numbers and give us confidence that the device will work as expected across a range of care settings and patients, Safabakhsh said.

To date, AgileMD's eCART is the only FDA-approved clinical deterioration prediction device that has undergone independent, multi-center, real-world testing with patients on risk-stratified units, a key differentiator for hospital leaders as they seek to make smart technology choices, he noted.

Health systems are trying to effectively lower mortality and length of hospital stay for all patients while also not overburdening frontline clinical teams with countless alerts and scores, Safabakhsh said.

Sepsis has been a major focus of clinical quality improvement over the last few years as it is the leading cause of in-hospital deterioration and death, but many other conditions also lead to death and transfers from the ward to the ICU level. Safa Baksh explained that eCART, a device that diagnoses clinical deterioration from any cause, gives clinicians a clear, real-time understanding of which patients are most in need of medical attention. Embedded clinical guidelines and pathways then enable these teams to escalate care more quickly when there is still time to intervene.

Culture of Innovation

The original team included several collaborators from across the university who connected through programs and workshops at what would become the Polsky Center for Entrepreneurship and Innovation.

In 2011, under the name Agile Diagnosis, they won first place in the Edward L. Kaplan, ’71, New Venture Challenge (NVC), and the top-ranked accelerator program helped them develop a business plan, refine their mission, and acquire the resources and capital to launch their business.

“The NVC class structure taught us how to clearly articulate our story and communicate both the opportunity we saw and the value we could create. Our instructors, coaches, and judges gave us valuable feedback that propelled us forward. It also helped us forge relationships with investors who believed in our mission and still support our work today,” Safa Baksh said.

We wouldn’t be in the position we are today without the support of NVC, the Polsky Center, and the incredible innovation culture at the University of Chicago.

Today, what started as a mobile app has evolved over the past decade into a platform used by over 135,000 clinical users across more than 250 hospitals.

“We learned the importance of integrating our products directly into electronic health records, and that's the focus of our current products and services,” Safabakhsh said, noting the value of the company's partnerships with the major health systems in the country.

“We founded AgileMD with the belief that technology can improve healthcare, and now we're extremely focused on demonstrating that providing evidence-based care not only improves patient outcomes, but also impacts key hospital metrics,” he added. Other co-founders include Dana Edelson (MD 01, MS 07), former assistant professor of medicine at the University of Chicago Hospitals and chief medical officer;

In addition to NVC, AgileMD has also received support from leading startup incubators MATTER, Y-Combinator and Rock Health. Since its founding, the company's work has been recognized with 80 peer-reviewed publications and has received nearly $3 million in federal grant funding from the Department of Health and Human Services, including the National Institutes of Health and the Office of Strategic Preparedness and Response (ASPR).

This article is by Melissa Fassbender, Senior Associate Director of External Relations and Science Communications at the Polsky Center. Melissa is a former journalist and has served as an editor for a variety of global publications in the areas of drug development, clinical trials, and design engineering. Contact Melissa by email or on Twitter: @melfass.

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