FDA clears Clario's SpiroSphere® with wireless ECG, streamlining data collection in clinical trials

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. "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, Executive Vice President, Cardiac, Respiratory & Precision Motion at Clario 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."

This new product not only represents a technological advancement but also offers a cost-effective solution for enhanced efficiency and patient experience. For more information about the SpiroSphere® ECG and other Clario endpoint solutions, please visit Clario.com.

About Clario
Clario is a leading healthcare research and technology company that generates high clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints.

Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2019.

For more information, go to Clario.com or follow us on LinkedIn.

Media Contact:
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