Respiree secures FDA 510(k) extension for cardio-respiratory wearable

The RS001 chest-worn device directly measures respiration and provides passive cardio-respiratory monitoring.

The US Food and Drug Administration (FDA) has granted a second 510(k) clearance to expand the use of Respiree’s RS001 cardio-respiratory wearable to home-based settings.

The clearance includes approval for the company’s 1Bio connected care platform, which leverages data from electronic health records (EHR) and its FDA-cleared, US-patented sensors for tracking the progression of the disease longitudinally.

The RS001 links to a cellular hub, facilitating the real-time visualisation of data through the 1Bio dashboard.

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