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U-M startup AlertWatch gains FDA clearance to sell patient monitoring software

Infographic describing how patient monitoring works with AlertWatchANN ARBOR—AlertWatch Inc., a University of Michigan startup, has gained U.S. Food and Drug Administration clearance to sell its patient monitoring software to hospitals.

AlertWatch helps anesthesia providers monitor patients in the operating room. The software aggregates data from physiological monitors, anesthesia records, lab results and medical history to produce a dynamic real-time display of a patient's condition.

The system continually analyzes the data and helps determine whether things are normal, marginal or abnormal (green, yellow and red colored icons).

"We've had a lot of interest from clinicians who have seen the demo. Now that we're over the FDA hurdle, it'll be great to get the product into their hands " said AlertWatch CEO Justin Adams. The company gained clearance this month.

Adams said preliminary data from analyzing more than 17,000 surgeries at U-M Health System comparing operations using AlertWatch with those not using it was presented at the recent meeting of the Society of Technology in Anesthesia. The initial data show promising results for the AlertWatch system.

Ann Arbor-based AlertWatch was founded in 2012 by U-M professor and anesthesiologist Dr. Kevin Tremper, chair of the Department of Anesthesiology.

"Forty years ago, we used the familiar wavy lines—EKG, heart rate and blood pressure—to monitor our patients," Tremper said. "Today, we're still using the same wavy lines, but we have all of this other patient information digitized and available. I wanted a tool that helped put all of that background patient information in context with everything else going on live in the operating room."

Pictured from left: Dr. Bagian, Dr. Tremper, and Justin AdamsPictured from left: Dr. Bagian, Dr. Tremper, and Justin AdamsThe founding team also includes Dr. James Bagian, a veteran astronaut and faculty member in both industrial engineering and anesthesiology. His research has focused on patient safety, including as the founding director of the National Center for Patient Safety and the first chief patient safety officer for the Veterans Health Administration.

"The problem is pretty straightforward," Bagian said. "The amount of data being produced for each patient is increasing, the complexity of care is increasing and the number of people involved in that care keeps going up, but the practitioner's ability to process all of the data remains fairly constant."

In addition to pilots running at the University of Tennessee and University of Vermont, Adams said the company hopes to kick off installations at several large U.S. hospitals. AlertWatch also hopes to raise venture funding in 2014 to support sales and further R&D.

"AlertWatch has made impressive progress in their regulatory requirements and is a great example of the digital health opportunities from the university," said Ken Nisbet, associate vice president of U-M Tech Transfer. "Congratulations to the entire team."

Tremper, Bagian and staff members Jan Gombert, Jenny Mace and Theodore Tremper hold equity in AlertWatch. The university also holds equity in the company and may profit from sales of this software.

 

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