GI Logic gets FDA clearance for connected wearable stethoscope
GI Logic has received FDA 510(k) clearance for a novel device that noninvasively monitors the digestive system after patients have surgery. The device, called AbStats, consists of two disposable sensors, a telemetry monitor, and a tablet app.
“Cardiology has this portable Holter monitor that can measure heart attacks in realtime, find out if someone’s having an arrhythmia, and phone up their doctor as it’s happening,” Dr. Brennan Spiegel, the director of health services research at Cedars-Sinai Health System who helped develop the device and has been testing it at Cedars-Sinai, says in a video on GI Logic’s website. “But in gastroenterology all we have is a stethoscope. This is something that was invented in 1816.”
The use case for the device is with patients who have recently had surgeries, where anesthesia and pain medication can sometimes cause the digestive system to temporarily shut down. It essentially attaches two connected stethoscopes to the patient, which listen to see when the system “reawakens” and it’s safe for the patient to start eating again.
“People wonder if bowel sounds are meaningful,” Spiegel continues in the video. “And well, not really, but if we can connect that same stethoscope we’ve been using since 1816, miniaturize it, make it portable, and connect it to a computer, now we have a brand new way of understanding the way the intestines work.”
In published, peer-reviewed studies, the company has shown that AbStats performs comparably to esophageal manometry, the standard of care. Manometry is expensive and invasive; it involves inserting a tube all the way into the patient’s stomach.
GI Logic will launch the device in the United States in 2016, the company said in a statement, and look to expand to other markets in the future.
“Digestive diseases are extraordinarily prevalent and expensive in the United States and beyond,” Spiegel said in a statement. “The cost of mismanaging post-operative feeding decisions, in particular, approaches $1 billion annually. As a health services researcher focused on maximizing the value of care, I view AbStats as a digital device with great potential to reduce costs while improving outcomes. That’s the ultimate goal of the emerging digital health movement, and a rare opportunity for any single biosensor to achieve.”
Spiegel spoke at a conference in February about another digital health gastro-intestinal tool he’s involved with, an app called My GI Health.