Home » FDA Grants 510(k) Clearance to Onera’s Sleep Study System
FDA Grants 510(k) Clearance to Onera’s Sleep Study System
Onera Health has received 510(k) clearance from the FDA for its Onera STS (sleep-study system) for at-home use in sleep studies.
The patch-based product, in combination with the company’s digital health platform, supports its polysomnography (PSG) service for clinical-grade sleep studies.
The company said the patch-based technology is less cumbersome and expensive than existing sleep-testing methods and noted an increased acceptance of at-home diagnostics in recent years.
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