FDA clears Clario's SpiroSphere® with wireless ECG, streamlining data collection in clinical trials USA - English USA - English
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~ Philadelphia, June 13, 2024 - Clario, a leading provider of technologies and endpoint data solutions for clinical trials, has announced the U.S. Food and Drug Administration (FDA) clearance of its SpiroSphere® with the wireless COR-12 Electrocardiogram (ECG) device. This groundbreaking integration allows for the consecutive collection of spirometry and ECG data during a single site visit through Clario's SpiroSphere® platform.

The FDA 510(k) clearance marks a significant milestone in clinical trial technology, as it streamlines the process by consolidating all data into a single, unified database. This eliminates the need for separate ECG devices or multiple databases for a study, making it more efficient and cost-effective.

Originally launched in 2018, the SpiroSphere®, a smart and lightweight pulmonary function testing (PFT) device, did not include ECG functionality. However, with the introduction of the SpiroSphere® ECG featuring the wireless COR-12 ECG device, customers can now conduct integrated respiratory and cardiac safety trials on one device and one database.

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Tom Stuckey, Senior Vice President of Respiratory & Precision Motion at Clario, stated that "the launch of our FDA-cleared SpiroSphere® wireless ECG device represents a significant step in improving clinical trial technology." He also emphasized their commitment to optimizing data collection, efficiency, and consistency in delivering respiratory trials with cardiac safety.

The wireless feature of the SpiroSphere® ECG not only improves patient experience by removing the need for lead wires but also maintains high-quality data collection standards. This advancement enables site clinicians to comfortably record both ECG and spirometry data in one session on a single device. It reduces burden on patients and accelerates trial timelines.

Ellen Street, Executive Vice President of Cardiac, Respiratory & Precision Motion at Clario added that "our SpiroSphere® wireless ECG focuses on the site and patient experience while maintaining high-quality data collection standards." She also highlighted the cost-effective solution this product offers for enhanced efficiency and patient experience.

For more information about the SpiroSphere® ECG and other Clario endpoint solutions, please visit Clario.com. This technological advancement is set to revolutionize respiratory trials with cardiac safety, making it easier and more efficient for sponsors to conduct comprehensive trials.
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