FDA OKs Koala Toco Disposable Tocodynamometer for U.S. Market

October 22, 2014

A collaboration between researchers at the University of Arkansas at Little Rock and the University of Arkansas for Medical Sciences has paid off with FDA clearance of an inexpensive, disposable, external medical device that monitors contractions in pregnant women.

The Koala Toco tocodynamometer is produced by Murray, Utah-based Clinical Innovations and consists of a small plastic disk that rests on the woman’s abdomen. When the uterus contracts, it pushes against the intrauterine wall, causing the internal pressure to rise. That compresses the air in the uterus, which produces a signal. The signal is then transmitted through an attached cable plugged into a fetal heart rate monitor, explained UALR researcher James D. Wilson. 

Other tocodynamometers are heavier and must be continually sterilized due to contact with perspiration, bodily fluids and medical gels, according to the company. At just $15 each, the Koala Toco can be tossed out after use, Wilson said. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.