The U.S. Food and Drug Administration (FDA) has requested additional efficacy information on the Apnea Risk Evaluation System (ARES TM). Company officials informed customers with a letter that detailed the FDA’s request to obtain more data on the respiratory effort signal found within the ARES Model 610.
In a letter issued by the manufacturer of the ARES users of the device were notified that the FDA has advised the Ares does not provide data consistent with the measurement of respiratory effort.
In the interim, company engineers will remove the respiratory effort signal from ARES labeling and disable its capability within the Model 610. Company officals, apologized for the inconvenience while assuring customers they were working diligently with the FDA to satisfy their requests.