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The FDA approval for sleep apnea is based on two company-sponsored trials encompassing about 470 participants, one in which patients were being treated with continuous positive air pressure, or ...
McGinnis developed the "Nasal CPAP Mask System," a continuous positive airway pressure (CPAP) machine for the treatment of sleep apnea, [3] based on the original 1981 design by Dr. Colin Sullivan. [4] After receiving FDA approval in 1984, Respironics began selling the first commercially available CPAP machine a year later. [5]
ResMed Inc. is an American medical equipment company based in San Diego, California.It primarily provides cloud-connectable medical devices for the treatment of sleep apnea (such as CPAP devices and masks), chronic obstructive pulmonary disease (COPD), and other respiratory conditions.
The FDA said it had received reports of people facing thermal issues such as fire, smoke, burns, and other signs of overheating while using Philips' DreamStation 2 CPAP machines.
Home medical equipment is a category of devices used for patients whose care is being managed from a home or other private facility managed by a nonprofessional caregiver or family member. It is often referred to as "durable" medical equipment (DME) as it is intended to withstand repeated use by non-professionals or the patient, and is ...
The FDA investigator noted that dating to 2008, Philips had gotten more than 222,000 consumer complaints that included keywords such as "contaminants, particles, foam, debris, airway, particulate ...
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