After nearly three years, the Department of Justice and the Food and Drug Administration have finally agreed to the terms of a consent decree with Philips. It states that Philips Respironics cannot manufacture or distribute new sleep and respiratory care devices in the U.S. market until certain criteria are met, unless the devices are classified by the FDA as “medically necessary.” The scope of the recall is far larger than just consumer PAP devices. This impacts sleep diagnostics – including Alice polysomnography systems, home sleep apnea test platforms, and in-lab titration devices. Here to help us understand the specifics of the consent decree are Drs. Peter Gay, Aneesa Das, and Robert Owens.

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