FDA puts ARES Respiratory Signal on Hold

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.

Source: SleepScholar

Randy Clare

Randy Clare

Randy Clare brings to The Sleep and Respiratory Scholar more than 25 years of extensive knowledge and experience in the sleep and pulmonary function field. He has held numerous management positions throughout his career and has demonstrated a unique view of the alternate care diagnostic and therapy model. He is considered by many an expert in the use of a Sleep Bruxism Monitor in a dental office. Mr. Clare's extensive sleep industry experience assists Sleepandrespiratoryscholar in providing current, relevant, data-proven information on sleep diagnostics and sleep therapies that are effective for the treatment of sleep disorders. Mr Clare is a senior brand manager for Glidewell Dental Laboratory his focus is on dental treatment for sleep disordered breathing.

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