GI Logic’s AbStats System receives FDA 510K clearance for real-time digestive telemetry

GI Logic

Recovery after surgery is frequently associated with diminished gastrointestinal function because anesthesia, pain medications and the surgery itself “shuts down” the digestive system. As a result, many post-operative patients suffer gastrointestinal dysfunction and cannot tolerate food until post-operative digestion is re-awakened. Physicians and nurses often struggle with the timing of feeding, as either feeding too early or too late can result in negative consequences for the patient.

In the two different trials, AbStats demonstrated its ability to predict which patients would get into trouble with post-operative feeding.GI Logic’s AbStats System, which consists of two AbStats Vibratory Sensors placed on the abdomen and the AbStats Telemetry Monitor, comes to the rescue and has just been cleared by the FDA — it can now be used by physicians in hospitals and other healthcare settings for non-invasive, real time telemetry of the digestive system. The AbStats System allows care providers to see digestive signals as they occur and evaluate the rate of digestive activity to determine when the GI tract re-engages.

“We are very pleased to have received this initial FDA 510K clearance for the AbStats System, the first easy-to-use, reliable digestive telemetry system for surgeons and gastroenterologist,” said James Beeton, co-founder and CEO of GI Logic. “We will be introducing the AbStats System in the US in 2016 and plan to expand with additional indications and to additional markets following our successful introduction in the US market.”

In the two different trials, AbStats demonstrated its ability to predict which patients would get into trouble with post-operative feeding. 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.”