Software-as-Medical Device: Qualcomm, AlertWatch Engage in Licensing Agreement

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Qualcomm Incorporated, through its wholly owned subsidiary, Qualcomm Life, Inc., has announced an exclusive strategic licensing agreement with AlertWatch, Inc., an Ann Arbor based company that pioneered the development of one of the first FDA-cleared intelligent care software systems to assist the real-time care of patients in the operating room.

The agreement provides Qualcomm Life with exclusive rights to market and sell AlertWatch:OR, an FDA-cleared Class II software-as-medical device (SaMD) used by clinicians for secondary monitoring of patients in operating rooms.

Developed at the University of Michigan Health System, AlertWatch:OR leverages data streamed from Qualcomm Life’s Capsule™ platform with electronic medical record feeds to provide real-time intelligence to anesthesiologists to help guide the care of patients during surgery.

AlertWatch’s software is used in tandem with other operating room patient monitors to analyze fluid and drug levels, blood loss, vital signs, and test results. The application also contains information about pre-existing conditions and medical history so physicians have a clear picture on the patient’s overall health. AlertWatch:OR can be accessed remotely, via mobile application or desktop, making it possible for care teams to supervise remotely and provide support based on priority when issues arise.

BMC Anesthesiology’s recently published article, authored by Kevin K. Tremper, PhD, MD, University of Michigan chief anesthesiologist and founder of AlertWatch and other members of the AlertWatch team, details AlertWatch’s design and capabilities. In a four-year study of over 27,000 patients at the University of Michigan, researchers found that the use of the AlertWatch software demonstrated improved process measures, reduced hospital charges and, when compared to cases where AlertWatch was not used, reduced hospital length of stay.

“The AlertWatch technology integrates medical data from a variety of sources and processes the data through several algorithms to deliver real-time monitoring, alerts and actionable insights, allowing care teams to identify potential issues in advance,” said James Mault, MD, FACS, senior vice president and chief medical officer, Qualcomm Life, Inc. “This ground-breaking example of software as a medical device aligns with our strategy of enabling predictive analytics solutions throughout the care continuum and is an important leap forward into the new era of intelligent care.”

“At AlertWatch, we believe that integrating multiple streams of data into a live, readily identifiable icon display can improve the safety of acute care medicine just as it has done in modern aviation,” said Kevin Tremper, PhD, MD, founder and president, AlertWatch, Inc. “Collaborating with Qualcomm Life to offer our service in tandem with the Capsule product line will increase the reach of AlertWatch and help enhance patient monitoring throughout the hospital.”


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