FDA Clears Clario's SpiroSphere® with Wireless ECG, Enhancing Data Collection in Clinical Trials

Friday, June 14, 2024

Clario, a leading provider of clinical trial technologies and endpoint data solutions, announced today that its SpiroSphere® device has received FDA 510(k) clearance for integration with the wireless COR-12 Electrocardiogram (ECG) device.

This development enables the simultaneous collection of spirometry and ECG data during a single site visit using Clario's SpiroSphere® platform, which consolidates all data into a single, unified database.

This innovation simplifies the clinical trial process, removing the need for separate ECG devices and multiple databases.

Originally launched in 2018, the SpiroSphere® is a lightweight pulmonary function testing (PFT) device that initially did not include ECG capabilities.

The addition of the wireless COR-12 ECG device now allows customers to conduct integrated respiratory and cardiac safety trials with one device and one database, streamlining the clinical trial process.

"The introduction of our FDA-cleared SpiroSphere® wireless ECG device is a significant milestone in clinical trial technology," said Tom Stuckey, Senior Vice President, Respiratory & Precision Motion at Clario.

"This clearance and product launch highlight our dedication to enhancing data collection, efficiency, and consistency, thus improving the delivery of respiratory trials with cardiac safety."

Respiratory & Precision Motion at Clario, added, "Our SpiroSphere® wireless ECG prioritizes the site and patient experience while maintaining the high-quality data collection standards of our wired ECG model.

With this wireless technology, clinicians can conveniently record both ECG and spirometry data in a single session using one device. This reduces the need for multiple devices, lessens the burden on sites, and accelerates trial timelines."

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







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