Clario has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its SpiroSphere with the integrated wireless COR-12 electrocardiogram (ECG) device.

The clearance enables the consecutive collection of spirometry and ECG data during a single visit to the site, streamlining clinical trial processes.

Originally launched in 2018 as a pulmonary function testing device, the SpiroSphere now boasts the addition of the wireless COR-12 ECG. This integration facilitates comprehensive respiratory trials with cardiac safety ECG collection on a single device.

The wireless feature of the SpiroSphere ECG is designed to improve patient experience by eliminating the need for physical connections between the recorder and the device.

Clario Respiratory and Precision Motion senior vice-president Tom Stuckey said: “The launch of our FDA-cleared SpiroSphere wireless ECG device represents a significant step in improving clinical trial technology.

“This clearance and product launch emphasises our commitment to optimizing data collection, efficiency, and consistency, further enhancing how we deliver respiratory trials with cardiac safety.”

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According to Clario, the wireless COR-12 ECG’s flexibility allows for integrated respiratory and cardiac safety trials that can be adapted for on-site, hybrid, or remote trial designs.

Clario Respiratory and Precision Motion cardiac executive vice-president  Ellen Street said: “Our SpiroSphere wireless ECG focuses on the site and patient experience while maintaining the high-quality data collection standards as our wired ECG model.

“With this wireless technology, site clinicians can now comfortably record both ECG and spirometry data in a single session on a single device, which can reduce the necessity for multiple devices, reduce burden, and accelerate trial timelines.”

Last year, Clario introduced the ECG Quality Score tool, which is powered by AI, for improving cardiac safety evaluations in clinical trials.