Clario, a provider of software to help drugmakers advance treatments through clinical trials, has filed confidentially for an initial public offering and is targeting a valuation of more than $10 billion, people familiar with the matter said.

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 lead wires while maintaining high-quality data collection and accelerating trial timelines.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

Clario partners with Emsere to extend ophthalmic medical imaging capabilities for clinical trials.