FDA Clearance Received for Wearable Biosensor that Enables Physicians to Monitor Digestion and Determine When Patients Can Safely Eat After Surgery
Los Angeles – Dec. 18, 2015 – A disposable biosensor, developed by a Cedars-Sinai physician to help doctors predict which abdominal surgery patients will have postoperative complications, received clearance this week from the U.S. Food and Drug Administration (FDA).
The one-inch sensor, which adheres to a patient’s skin, assesses “intestinal vital signs” by recording and analyzing sounds made in the stomach. This data helps doctors to predict which patients will have postoperative ileus — a common condition that prevents the digestive system from functioning properly after surgery. Patients with this condition who are given food too soon following surgery can experience severe abdominal pain, nausea, vomiting, abdominal distention and even life-threatening illnesses.
The biosensor – which received FDA clearance on Dec. 14 — provides physicians with real-time medical information that can inform feeding decisions. Currently, doctors have no reliable means of prospectively diagnosing the postoperative abdominal complication. Empirically based feeding decisions can help speed recoveries, shortening lengths of stay and reducing healthcare costs.
A study highlighting the biosensor’s potential appears in the Journal of Gastrointestinal Surgery.
“With the biosensor, we can now record bowel sounds, which we consider a new vital sign that should be monitored along with heart rate, blood pressure and respiration,” said Brennan Spiegel, MD, MSHS, the study’s primary investigator and director of Health Services Research at Cedars-Sinai.
Spiegel, who also serves as director of the Cedars-Sinai Center for Outcomes Research and Education, developed the patented digital device with William Kaiser, PhD, UCLA Henry Samueli School of Engineering and Applied Science. The biosensor is being evaluated further in an ongoing clinical trial.
The computer-connected biosensor — called an acoustic gastrointestinal surveillance biosensor — monitors and assesses intestinal activity. Researchers found that the biosensor predicted the abdominal condition in patients with more than 80-percent accuracy, allowing physicians to confidently delay food intake when necessary. Patients not at risk for digestive difficulties can be started on food, which promotes wound healing and improves outcomes.
Phillip Fleshner, MD, director colorectal surgery research at Cedars-Sinai, had several patients in the study and finds the results intriguing. “There’s been no way to tag these patients or markers to guide our feeding decisions,” Fleshner said. “This device may fill that void by forecasting who will do well on advanced feeding schedules.”
The biosensor could have applications beyond postoperative ileus. “For example, the device may be helpful to monitor people suffering from pancreatitis, inflammatory bowel disease and irritable bowel syndrome,” Spiegel said. “We’re also exploring the potential for using similar biosensors in the management of preterm infants in the neonatal intensive care unit because determining when to feed them is a huge issue.”
Starting in 2016, the biosensor technology will be marketed by medical-device company GI Logic under the brand name Abstats®System.
Additional Cedars-Sinai researchers involved in this study include Marc Kaneshiro, MD; Jonathan Pourmorady, MD; Karen Zaghiyan, MD; Bibiana Martinez, MPH; Mark Reid, PhD; Francis Dailey, MD; Jason Xu, MD; and Karen Robbins, MD.