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Home » FDA clears Clario SpiroSphere with wireless ECG

FDA clears Clario SpiroSphere with wireless ECG

June 13, 2024 By Sean Whooley

Clario SpiroSphere
The SpiroSphere system. [Image from the Clario website]
Clario announced today that it received FDA 510(k) clearance for its SpiroSphere with the wireless COR-12 electrocardiogram (ECG) device.

SpiroSphere paired with ECG enables the consecutive collection of spirometry and ECG data during a single site visit. The platform consolidates all data into a single, unified database and streamlines the clinical trial process. It also eliminates the need for separate ECG devices or multiple databases for a study.

Philadelphia-based Clario originally launched SpiroSphere as a smart, lightweight pulmonary function testing (PFT) device. It initially did not include ECG functionality. However, introducing the wireless COR-12 ECG device enables customers to run integrated respiratory and cardiac safety trials on a single device and single database.

Clario SVP of Respiratory & Precision Motion, Tom Stuckey, called the device launch a “significant step in improving clinical trial technology.” Stuckey said the system optimizes data collection, efficiency and consistency to enhance respiratory trials with cardiac safety.

“Our SpiroSphere® wireless ECG focuses on the site and patient experience while maintaining the high-quality data collection standards as our wired ECG model,” said Ellen Street, EVP, Cardiac, Respiratory & Precision Motion at Clario. “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.”

Filed Under: Big Data, Cardiovascular, Clinical Trials, Health Technology, Patient Monitoring, Respiratory, Software / IT Tagged With: Clario

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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