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.