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.

• Clario’s SpiroSphere® integration with the wireless COR-12 is now FDA 510(k) cleared, allowing for consecutive collection of spirometry and ECG data during a single site visit.
• The flexibility of the wireless COR-12 ECG enables integrated respiratory and cardiac safety trials for on-site, hybrid or remote trial design considerations.
• The wireless feature of the SpiroSphere® ECG improves patient experience by removing the need for a physical connection of the recorder to the SpiroSphere® device while maintaining high-quality data collection.

PHILADELPHIA – June 13, 2024 – 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.”

Ellen Street, Executive Vice President, Cardiac, Respiratory & Precision Motion at Clario added, “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.”

This new product not only represents a technological advancement but also offers a cost-effective solution for enhanced efficiency and patient experience. For more information about the SpiroSphere® ECG and other Clario endpoint solutions, please visit Clario.com.