Dehaier Medical Systems has secured China State FDA approval for DHR-CPAP-C5, a homecare continuous positive airway pressure (CPAP) device for the first line of treatment for obstructive sleep apnoea syndrome (OSAS) and for some forms of central sleep apnoea. The period of validity for the SFDA approval is four years.
CPAP works by creating a pneumatic splint for the upper airway. A flow generator sends pressurised air through air tubing and a mask (usually a nasal mask) and through the nose to the upper airway. The pressurised air prevents the soft tissues of the upper airway from narrowing and collapsing. For proper CPAP treatment, patient can set high enough flow generator pressures to prevent apneas and hypopneas during all sleep stages and in all sleep positions. The DHR-CPAP-C5 device will be launched in China shortly.
Separately, Dehaier has released its DHR-998 device for use in diagnosis and treatment evaluation for OSA in markets that recognise the CE mark. The latter was approved by the EU in 2011.