Sam Brusco, Associate Editor06.13.24
Clario has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its SpiroSphere with wireless COR-12 electrocardiogram (ECG) device.
The FDA nod allows consecutive spirometry and ECG data collection during one site visit through the SpiroSphere platform. This consolidates all the data into one, unified database, which can help streamline clinical trials and remove the need for separate ECGs or multiple databases in a study.
SpiroSphere was first launched in 2018 for smart, lightweight pulmonary function testing (PFT). It didn’t originally feature ECG functionalty. Now, including the COR-12 ECG device allows running integrated respiratory and cardiac safety trials on a single device and database to simplify the trial process.
"The launch of our FDA-cleared SpiroSphere wireless ECG device represents a significant step in improving clinical trial technology," said Clario senior VP of Respiratory & Precision Motion Tom Stuckey. "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."
Ellen Street, Clario’s executive VP, of Cardiac, Respiratory & Precision Motion added, "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."
The FDA nod allows consecutive spirometry and ECG data collection during one site visit through the SpiroSphere platform. This consolidates all the data into one, unified database, which can help streamline clinical trials and remove the need for separate ECGs or multiple databases in a study.
SpiroSphere was first launched in 2018 for smart, lightweight pulmonary function testing (PFT). It didn’t originally feature ECG functionalty. Now, including the COR-12 ECG device allows running integrated respiratory and cardiac safety trials on a single device and database to simplify the trial process.
"The launch of our FDA-cleared SpiroSphere wireless ECG device represents a significant step in improving clinical trial technology," said Clario senior VP of Respiratory & Precision Motion Tom Stuckey. "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."
Ellen Street, Clario’s executive VP, of Cardiac, Respiratory & Precision Motion added, "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."