In Australia, Sleep Specialists LLC Receives Regulatory Approval for Zzoma Sleep Apnea Device
The Therapeutic Goods Administration (TGA) in Australia has approved the Zzoma sleep apnea device for listing on the Australian Register of Therapeutic Goods (ARTG), announced Sleep Specialists LLC, a medical device company specializing in sleep therapy. This regulatory approval will allow the device to be sold in Australia.
“Various resources estimate that approximately one million Australians are affected by sleep apnea,” says Sila Yesilsoy, COO of Sleep Specialists, in a release. “Our research and collaboration with healthcare professionals in the country shows that positional obstructive sleep apnea [OSA] is prevalent among these individuals, and that many additional cases may be undiagnosed. We are excited to reach this regulatory milestone as it will enable thousands of Australians to benefit from using our Zzoma device.”
Positional OSA is a condition in which a person stops breathing for short periods of time while asleep in a supine or “on-the-back” position due to the narrowing or collapsing of the upper airway during sleep. Zzoma is a medical device worn around the upper torso that keeps patients asleep on their sides by preventing supine sleeping.