Trending...
- Bethany Nikitenko Appointed to Philadelphia Trial Lawyers Association Board of Directors
- Porter's Day Care Opens Doors to Brighter Futures
- Racquet Club of Philadelphia appoints Michael J. Sofia as new General Manager
~ Philadelphia, June 13, 2024 - Clario, a leading provider of technologies and endpoint data solutions for clinical trials, has announced the U.S. Food and Drug Administration (FDA) clearance of its SpiroSphere® with the wireless COR-12 Electrocardiogram (ECG) device. This groundbreaking integration allows for the consecutive collection of spirometry and ECG data during a single site visit through Clario's SpiroSphere® platform.
The FDA 510(k) clearance marks a significant milestone in clinical trial technology, as it streamlines the process by consolidating all data into a single, unified database. This eliminates the need for separate ECG devices or multiple databases for a study, making it more efficient and cost-effective.
Originally launched in 2018, the SpiroSphere®, a smart and lightweight pulmonary function testing (PFT) device, did not include ECG functionality. However, with the introduction of the SpiroSphere® ECG featuring the wireless COR-12 ECG device, customers can now conduct integrated respiratory and cardiac safety trials on one device and one database.
More on The PennZone
Tom Stuckey, Senior Vice President of Respiratory & Precision Motion at Clario, stated that "the launch of our FDA-cleared SpiroSphere® wireless ECG device represents a significant step in improving clinical trial technology." He also emphasized their commitment to optimizing data collection, efficiency, and consistency in delivering respiratory trials with cardiac safety.
The wireless feature of the SpiroSphere® ECG not only improves patient experience by removing the need for lead wires but also maintains high-quality data collection standards. This advancement enables site clinicians to comfortably record both ECG and spirometry data in one session on a single device. It reduces burden on patients and accelerates trial timelines.
Ellen Street, Executive Vice President of Cardiac, Respiratory & Precision Motion at Clario added that "our SpiroSphere® wireless ECG focuses on the site and patient experience while maintaining high-quality data collection standards." She also highlighted the cost-effective solution this product offers for enhanced efficiency and patient experience.
For more information about the SpiroSphere® ECG and other Clario endpoint solutions, please visit Clario.com. This technological advancement is set to revolutionize respiratory trials with cardiac safety, making it easier and more efficient for sponsors to conduct comprehensive trials.
The FDA 510(k) clearance marks a significant milestone in clinical trial technology, as it streamlines the process by consolidating all data into a single, unified database. This eliminates the need for separate ECG devices or multiple databases for a study, making it more efficient and cost-effective.
Originally launched in 2018, the SpiroSphere®, a smart and lightweight pulmonary function testing (PFT) device, did not include ECG functionality. However, with the introduction of the SpiroSphere® ECG featuring the wireless COR-12 ECG device, customers can now conduct integrated respiratory and cardiac safety trials on one device and one database.
More on The PennZone
- Contracting Resources Group Named to Inc. 5000 for the Ninth Time
- Nola Blue Records to Release John Németh's Illinois Central in March 2027
- ImagineX Named to 2026 Inc. 5000 List of America's Fastest-Growing Private Companies
- ASSIST Software Becomes One of the First European Companies Certified to ISO/IEC 42001
- The World's No.1 Superstar® Enters the Occult with New Track and Cinematic Visual "Under Your Spell"
Tom Stuckey, Senior Vice President of Respiratory & Precision Motion at Clario, stated that "the launch of our FDA-cleared SpiroSphere® wireless ECG device represents a significant step in improving clinical trial technology." He also emphasized their commitment to optimizing data collection, efficiency, and consistency in delivering respiratory trials with cardiac safety.
The wireless feature of the SpiroSphere® ECG not only improves patient experience by removing the need for lead wires but also maintains high-quality data collection standards. This advancement enables site clinicians to comfortably record both ECG and spirometry data in one session on a single device. It reduces burden on patients and accelerates trial timelines.
Ellen Street, Executive Vice President of Cardiac, Respiratory & Precision Motion at Clario added that "our SpiroSphere® wireless ECG focuses on the site and patient experience while maintaining high-quality data collection standards." She also highlighted the cost-effective solution this product offers for enhanced efficiency and patient experience.
For more information about the SpiroSphere® ECG and other Clario endpoint solutions, please visit Clario.com. This technological advancement is set to revolutionize respiratory trials with cardiac safety, making it easier and more efficient for sponsors to conduct comprehensive trials.
0 Comments
Latest on The PennZone
- XRPPower Expands Platform Security With Enhanced Brand Protection and Official Verification Standards
- Cuvo Health, the #1 White Label Telehealth Platform, Surpasses 300 Exclusive Providers Serving All 50 States
- Birkdale Investments LLC Acquires Assets of Mumbai Central Farmers Market, Unveils Expanded Vision
- RAS AP Consulting Expands Managed AP Governance™ Ecosystem, Launches Trademark Process, and Secures IFOL Speaker Invitation
- UK Financial Ltd Makes History: Chainlink CRE Circulating Supply Verification Goes Live Across Its Complete Ecosystem Of Nine Exchange-Traded Tokens
- International Rights Groups Raise Alarm Over Freedom of Religion and Expression in South Korea
- The City's Most Elegant Open-Air Dinner Party Returns September 12, 2026
- LiteracyNation's 3rd Annual Indie Author Book Fair
- FDA Clears Major Regulatory Hurdle as Preservative-Free Ketamine Program Moves Within Reach of Commercialization: NRx Pharmaceuticals: (NAS DAQ: NRXP)
- Autonomous Robotics Platform Expansion as Public Market Debut is Very Close: MBody AI Corp. (N A S D A Q: MBAI)
- Loud! OOH calls for prize draw advertising standards as £1.3bn category moves outdoors
- Insurance for Braces Helps Make Treatment More Manageable for Pennsylvania Families
- Black Ribbon Productions Launches With Fearless 2026 Horror Slate
- Actor Dominic Pace Returns to Television and Film
- Opteamix welcomes Girish Ramachandra to its leadership team as Senior Vice President of Client Services
- Silicon Box Ships 500M Units at High Yield, Expands Production Capacity for Panel-Level Packaging
- Bethany Nikitenko Appointed to Philadelphia Trial Lawyers Association Board of Directors
- Why Baton Rouge's Humid Climate Can Contribute to Carpenter Ant Damage — J&J Exterminating Explains How to Protect Your Home
- Meals on Wheels of the Greater Lehigh Valley Awarded $50,000 Grant from Harry C. Trexler Trust
- RPR Promotes Emily Line to Chief Strategy Officer and Janine Sieja to Chief Product Officer