Samsung has announced the availability of its Sleep Apnea detection feature for Galaxy Watch users in Malaysia following the feature’s approval by the Medical Device Authority (MDA) of Malaysia, which issued a Medical Device Registration Certificate confirming that the feature complies with local regulatory standards.
Sleep Apnea Detection Now Live In Malaysia
The Sleep Apnea feature is designed to help users detect potential symptoms of the condition by monitoring sleep patterns along with blood oxygen levels (SpO₂) via the BioActive sensor, alerting the user of potential symptoms while providing sleep coaching and optimizing sleep environments. When unmitigated, sleep apnea – meaning a user stops breathing during sleep – can result in poorer sleep quality, along with complications like hypertension, cardiac disorder, stroke, and cognitive disorder.
Prior to Malaysia’s approval, the feature has been approved by Australia’s Therapeutic Goods Administration, Singapore’s Health Sciences Authority, the U.S. Food and Drug Administration (FDA), Korea’s Ministry of Food and Drug Safety, Brazil’s ANVISA, and Health Canada. The FDA’s De Novo authorization notably made Samsung the first company to receive clearance for a wearable device capable of detecting signs of moderate to severe obstructive sleep apnea.
Note that the feature, accessible via Samsung Health Monitor app, is available for Galaxy Watch4 series and newer models running Wear OS 5.0 or later, paired with a Galaxy smartphone operating on Android 12.0 or higher.
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