Born at UChicago, AgileMD Takes Strides to Expand Healthcare Tech with Recent FDA Nod

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

Founded at the University of Chicago by business school students at Booth and physician-researchers at the hospital, AgileMD has announced significant steps in expanding the adoption of its AI-powered software – and its mission to improve healthcare with technology.

The company’s software as a medical device uses a machine learning algorithm to continuously assess patient status in the hospital, assisting medical staff in quickly recognizing those that require increased medical attention. And this week, it has announced that the “eCART Clinical Deterioration Suite” has been granted 510(k) marketing clearance from the FDA.

Directly embedded into electronic health records, the software draws from nearly 100 real-time variables, including labs, vital signs, and nursing assessments, to generate an eCART score and risk designation. Clinical staff are then guided to embedded clinical pathways for care evaluation and management.

CEO Borna Safabakhsh, MBA ’11

Speaking to the importance of the FDA clearance, Borna Safabakhsh, MBA ’11, cofounder and CEO of AgileMD, noted industry attention on where and how the “promise of AI in medicine” is delivered.

“We are seeing growing appreciation for the idea that sophisticated models used in the management of patients need to be independently evaluated in a real-world setting,” he explained. “From our perspective, this clearance represents a shift toward that thinking.”

The model has been trained on nearly a million patient encounters from seven hospitals and tested on almost two million separate patient encounters from an additional 21 hospitals. “These are enormous numbers that give us confidence that this device will perform as expected across a wide variety of care settings and patients,” said Safabakhsh.

To date, AgileMD’s eCART is the only FDA-cleared clinical deterioration prediction device that has undergone independent multi-center real-world testing for risk-stratifying ward patients, he noted – an important differentiator as hospital leadership looks to make smart technology choices.

“Health systems are trying to bring down mortality and length of stay in a meaningful way – across all patients – while at the same time not overburdening their frontline clinical teams with a myriad of alarms and scores,” said Safabakhsh.

While sepsis specifically has been a major focus of clinical quality improvement for several years, as it is the leading cause of in-hospital deterioration and death, many other medical conditions lead to death or ICU-level transfer from the ward. An “all-cause clinical deterioration device,” eCART provides clinicians with a “clear, real-time understanding of which patients need medical attention most,” explained Safabakhsh. “Then, with embedded clinical guidelines and pathways, these teams are empowered to escalate care faster, when the time to intervene is still on their side.”

A ‘Culture of Innovation’

The original team included several collaborators from across the University who were connected through programs and workshops at what became the Polsky Center for Entrepreneurship and Innovation.

In 2011, they took first place in the Edward L. Kaplan, ’71, New Venture Challenge (NVC). The top-ranked accelerator program helped them develop their business plan, refine the mission, and gain resources and capital to help launch the business.

“The structure of the NVC class taught us how to clearly articulate our story and communicate both the opportunity we saw and the value we could create. The instructors, coaches, and judges gave us invaluable feedback that moved us forward, and we built relationships with investors who believe in our mission and still support our work today,” said Safabakhsh.

“We wouldn’t be where we are today without the support of the NVC, the Polsky Center, and the amazing culture of innovation at UChicago.”

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

“We have learned the importance of integrating our products directly into the electronic health record, which is where our products and services focus today,” said Safabakhsh, noting the value of the company’s partnership with major health systems around the country.

“We founded AgileMD with a belief that we could improve healthcare with technology, and we now focus a tremendous amount on demonstrating how delivering evidence-based care not only improves patient outcomes but also impacts critical hospital metrics,” he added. Fellow cofounders include Chief Medical Officer Dana Edelson, MD ’01, MS ’07, a hospitalist at UChicago.

In addition to the NVC, AgileMD also is backed by premier startup incubators MATTER, Y-Combinator, and Rock Health. Since it was founded, the company’s work has been evaluated in 80 peer-reviewed publications and has received nearly $3 million in federal grant funding from the Department of Health & Human Services, including the National Institutes of Health and the Administration for Strategic Preparedness and Response (ASPR).


Article by Melissa Fassbender, senior associate director of external relations and science communications at the Polsky Center. Melissa is a former journalist and has held the role of editor at various global publications in the drug development, clinical trials, and design engineering space. Reach Melissa via email or on Twitter at @melfass.


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