Andromed Initiates Its Multicenter Trial on Androflo

Andromed has initiated its clinical validation study on Androflo, a noninvasive diagnostic tool allowing the continuous real-time measurement of respiratory rate.

The study aims to show Androflo's equivalence to the capnometer -- an instrument incorporating an infrared detector assembly that is used in medical applications to monitor air exchange in the lungs of patients on ventilators or under anesthesia. The Androflo device measures respiratory rate based on sounds from the trachea. The data on 60 patients undergoing a colonoscopy will be compiled and analyzed.

"We are confident that this study's findings will enable us to file an application for FDA marketing approval by this summer," said Andromed's President and CEO Benoit Larose. "The FDA should then take about 90 days to evaluate our application, which means we can look forward to Androflo's approval by year-end."