FDA Approves Use of UCLA-created Wearable Device to Address Gastrointestinal Disorders

Jan 10, 2016

By UCLA Samueli Newsroom

The U.S. Food and Drug Administration has cleared the use of a device invented at UCLA that could improve care for patients with gastrointestinal problems.

The system of sensors and telemetry monitor, called AbStats™ System, provide a wearable, real-time assessment of a patient’s digestive function. Recently published clinical trial results show that AbStats not only detects but also enables prediction of the onset of the critical gastrointestinal conditions.

AbStats provides a data-driven, cost-effective method for determining protocols for patients recovering from gastrointestinal surgery and other health challenges.

AbStats technology, including novel sensors and signal processing analytics, was developed by the Wireless Health Institute (WHI) in the group of William Kaiser, a professor of electrical engineering at the UCLA Henry Samueli School of Engineering and Applied Science and co-director of WHI; in collaboration with Dr. Brennan Spiegel, a professor of medicine at the David Geffen School of Medicine at UCLA and the UCLA Fielding School of Public Health, and the director of Health Services Research at the Cedars-Sinai Health System.

The technology is licensed by UCLA to the medical device company GI Logic Inc., of Pasadena, Calif.

Gastrointestinal surgery, as well as related use of anesthesia and pain medications, may inhibit digestive system function for extended periods, leading to the condition referred to as Post Operative Ileus (POI). POI poses a risk to patients who return too quickly to a normal diet, often hindering their recovery and requiring extended and costly hospital stays. Adverse effects can also set in if patients wait too long to resume a normal diet.

Currently, medical providers can only assess the post-surgical recovery of the gastrointestinal system by placing a stethoscope over the intestines and or asking patients about discomfort and other symptoms.

The AbStats system continuously senses and analyzes the vibrational waves resulting from intestinal muscular motion events via a pair of sensors placed on the abdomen. AbStats data is displayed on a monitor. Physicians can then use the data to determine when the gastrointestinal system is returning to normal function. The AbStats system is being developed to address a range of digestive disorders, as well as to provide guidance for weight management and general diet optimization.

“Professor Kaiser’s innovation answers the urgent, unmet need for the first evidence-based method of detecting digestive function,” said Dr. Benjamin Wu, professor of bioengineering at UCLA and the executive director of the Wireless Health Institute.

The FDA cleared the AbStats system for use by physicians in hospitals and other healthcare settings on Dec 18, 2015.

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