US-based healthcare technology company Clario has received the US Food and Drug Administration (FDA) 510(k) approval for its SpiroSphere system for electrocardiogram (ECG).
The system is designed to run with the COR-12, a compact and wireless ECG device that transmits 12-channel ECG data via Bluetooth.
SpiroSphere enables consecutive collection of spirometry and ECG data during a single site visit, using the company’s SpiroSphere platform.
It consolidates all data into a single, unified database, simplifying the clinical trial process and eliminating the need for separate ECG devices or multiple databases for a study.
Clario respiratory and precision motion senior vice president Tom Stuckey said: “The launch of our FDA-cleared SpiroSphere wireless ECG device represents a significant step in improving clinical trial technology.
“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.”
SpiroSphere was initially launched in 2018, as a smart and lightweight pulmonary function testing (PFT) device, without featuring an ECG functionality.
The new version of SpiroSphere, with the wireless COR-12 ECG device, enables customers to run integrated respiratory and cardiac safety trials on a single device and single database.
This system not only represents a technological advancement but also offers a cost-effective solution for enhanced efficiency and patient experience, said the medical technology company.
Clario cardiac, respiratory and precision motion executive vice president Ellen Street said: “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.”
