FDA grants 510(k) clearance to under-mattress device that assists in OSA diagnosis - Healio
The FDA granted 510(k) clearance to the Sleep Rx Mat, an under-mattress device aiding in OSA diagnosis by tracking respiratory rate, body movement, heart rate, sleep cycles, and interruptions. It provides a sleep quality score and requires a prescription.
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FDA grants 510(k) clearance to under-mattress device that assists in OSA diagnosis - Healio
The FDA granted 510(k) clearance to the Sleep Rx Mat, an under-mattress device aiding in OSA diagnosis by tracking respiratory rate, body movement, heart rate, sleep cycles, and interruptions. It provides a sleep quality score and requires a prescription.