Free Design Audit Available - Click Here for Details

FDA clears Clario’s SpiroSphere® with wireless ECG, streamlining data collection in clinical trials

With the FDA 510(k) clearance of the COR-12 wireless ECG device now integrated with the SpiroSphere®, sponsors can conduct comprehensive respiratory trials with cardiac safety ECG collection on one device.

PHILADELPHIA, June 13, 2024 /PRNewswire/ — Clario, a leading provider of technologies and endpoint data solutions for clinical trials, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its SpiroSphere® with the wireless COR-12 Electrocardiogram (ECG) device. This technological advancement allows for the consecutive collection of spirometry and ECG data during a single site visit through Clario’s SpiroSphere® platform, consolidating all data into a single, unified database. This streamlines the clinical trial process and eliminates the need for separate ECG devices or multiple databases for a study.

Originally launched in 2018, the SpiroSphere®, a smart and lightweight pulmonary function testing (PFT) device, initially did not include ECG functionality. Now, the introduction of the SpiroSphere® ECG features the wireless COR-12 ECG device. This advancement enables customers to run integrated respiratory and cardiac safety trials on a single device and single database, simplifying the clinical trial process.

“The launch of our FDA-cleared SpiroSphere® wireless ECG device represents a significant step in improving clinical trial technology,” said Tom Stuckey, Senior Vice President, Respiratory & Precision Motion at Clario. “This clearance and product launch emphasizes our commitment to optimizing data collection, efficiency, and consistency, further enhancing how we deliver respiratory trials with cardiac safety.”

Sign up for Blog Updates