Clario’s SpiroSphere® with wireless ECG- FDA clears, simplifying clinical trial data collection.

Clario’s SpiroSphere The FDA has granted 510(k) clearance for the COR-12 wireless ECG device, now seamlessly integrated with SpiroSphere®. This integration enables sponsors to conduct comprehensive respiratory trials while collecting cardiac safety ECG data using a single device.

Clario’s FDA-cleared SpiroSphere® integration with the wireless COR-12 allows for simultaneous collection of spirometry and ECG data during a single site visit. The wireless capabilities of the COR-12 ECG device support integrated respiratory and cardiac safety trials, accommodating on-site, hybrid, or remote trial designs.

By eliminating the need for lead wires, the wireless SpiroSphere® ECG enhances patient experience and ensures high-quality data collection, thereby expediting trial timelines.

Clario has received FDA 510(k) clearance for its SpiroSphere® featuring the wireless COR-12 Electrocardiogram (ECG) device. This innovation enables simultaneous collection of spirometry and ECG data during a single site visit using Clario’s SpiroSphere® platform. It integrates all data into a unified database, simplifying the clinical trial workflow by eliminating the requirement for separate ECG devices or multiple databases.

In 2018, the SpiroSphere® was initially introduced as a smart and lightweight device for pulmonary function testing (PFT), lacking ECG functionality. Recently, Clario has enhanced the SpiroSphere® by integrating the wireless COR-12 ECG device. This addition allows for combined respiratory and cardiac safety trials using a unified device and database, streamlining the clinical trial process.

According to Tom Stuckey, Senior Vice President of Respiratory & Precision Motion at Clario, the FDA clearance and launch of the SpiroSphere® wireless ECG device mark a significant advancement in clinical trial technology. This development underscores Clario’s commitment to optimizing data collection, efficiency, and consistency, thereby improving the delivery of respiratory trials with integrated cardiac safety measures.

Ellen Street, Executive Vice President of Cardiac, Respiratory & Precision Motion at Clario, emphasized the advancements of their SpiroSphere® wireless ECG. She highlighted its ability to prioritize site and patient experience while upholding high standards in data collection, akin to their wired ECG model. This wireless technology enables clinicians to conveniently record both ECG and spirometry data in a single session on a unified device, potentially minimizing the need for multiple devices, easing burdens, and expediting trial timelines.

Beyond technological innovation, this product promises a cost-effective solution aimed at improving efficiency and enhancing patient experiences. For further details on the SpiroSphere® ECG and other endpoint solutions from Clario, please visit Clario.com.

Clario offers a cutting-edge cardiac monitoring solution as part of its comprehensive evidence-generation portfolio. This advanced device combines state-of-the-art technology with precise data collection capabilities, catering specifically to the needs of clinical trials in cardiovascular health.

The Clario cardiac monitoring device utilizes sophisticated sensors and wireless connectivity to continuously track and record crucial cardiac metrics such as heart rate variability, ECG signals, and arrhythmias in real time. Its seamless integration with Clario’s broader ecosystem of clinical trial solutions ensures streamlined data collection and analysis, enhancing efficiency and accuracy throughout the research process.

Moreover, the device adheres to rigorous regulatory standards, making it a trusted choice for pharmaceutical, biotech, and medical device partners seeking robust evidence to support product development and regulatory submissions. With its user-friendly interface and reliable performance, the Clario cardiac monitoring solution empowers researchers to gather actionable insights and drive meaningful advancements in cardiovascular care.

Through innovations like the cardiac monitoring device, Clario continues to uphold its commitment to advancing healthcare through scientific excellence and technological innovation, ultimately improving patient outcomes worldwide.

Clario’s SpiroSphere

Clario is a prominent healthcare research and technology firm specializing in generating robust clinical evidence for pharmaceutical, biotech, and medical device partners. Our offerings encompass comprehensive evidence-generation solutions integrating eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints.

With a history spanning more than five decades, Clario has been committed to providing extensive scientific expertise and a wide array of endpoint technologies, making significant contributions to global health outcomes. Our endpoint data solutions have been instrumental in supporting clinical trials on more than 26,000 occasions across over 100 countries. Moreover, our global team of experts in science, technology, and operations has contributed to over 60% of all FDA drug approvals since 2019.