FDA gives 510(k) clearance for AbStats System for gastro-intestinal diagnostics- GI Logic

GI Logic announced it has received FDA 510K clearance for the AbStats System to be used by physicians in hospitals and other healthcare settings for non-invasive, real time telemetry of the digestive system. The AbStats System consists of two AbStats Vibratory Sensors placed on the abdomen and the AbStats Telemetry Monitor. The monitor allows care providers to see digestive signals as they occur and evaluate the rate of digestive activity. This rate can help doctors determine when the GI tract re-engages. The data offers healthcare professionals objective data on which to base post-operative feeding protocols.

The Acoustic Gastro-Intestinal Surveillance (AGIS) biosensor monitors human digestion using acoustic signals, filling an unmet need in postoperative care and potentially saving significant time and money for patients and hospitals alike. A study has shown that AbStats is a valid measure of the intestinal 'engine' – it can tell whether the GI system is turned on or off, and when on, how fast it is working. The data showed that AbStats could predict which patients would get into trouble with post-operative feeding.