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FDA Clears Disposable Version of EEG-Based Home Sleep Test
['Sleep Review Staff']
Sleep Review
Complements the reusable Somfit, creating an EEG-based platform serving both high-volume single-use and multi-night reusable diagnostic marketsUS salesforce in place, providers already engaged, and commercial rollout commencing immediately.
Somfit D is now cleared in Australia, New Zealand, and the EU.
The Food & Drug Administration (FDA) has granted 510(k) clearance for Compumedics Ltd’s Somfit D device, a disposable version of the company’s EEG-based Somfit home sleep test (HST).
In combination with the reusable Somfit, Compumedics now delivers an EEG-based platform that spans both single-use and reusable markets.
“The FDA clearance of Somfit D is a transformational milestone for Compumedics,” says David Burton, PhD, executive chairman and CEO, in a release.
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