FDA Clears Home Diagnostic System for Sleep Apnea

Food and Drug Administration (FDA).

In an independent study conducted at the University of California, San Francisco (USA), sleep data obtained simultaneously using the new system and in-laboratory polysomnography demonstrated a 98% correlation. Results of the study were presented at the annual meeting of the American College of Chest Physicians in San Francisco.

Doctors can use the system, called Bedbugg, to remotely test for OSA and access quantitative results via the Internet or fax. The patient wears a small sensor for three nights and a bedside console collects data that are returned to Sleep Solutions, Inc. (Palo Alto, CA, USA), the developer of Bedbugg. Sleep solutions downloads and compiles the data and sends a comprehensive summary to the patient's doctor.

"It allows patients to undergo three nights of testing at their convenience, in the comfort of home rather than in a hospital or sleep lab,” noted Bruce Adomato, M.D., medical director of Sleep Solutions. "These unique features greatly enhance the prospect of obtaining useful and reliable data.”



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