Trending...
- Heritage at South Brunswick Introduces New Ferndale Floorplan: The Largest Single-Family Home Design in the Community - 203
- Mumbai Central Farmers Market Launches Community Collective for More Value and Connection
- KT Medical Staffing Addresses the Questions Families Forget to Ask Before Bringing Private Nursing Care Home
~ 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
- DuraFast Label Company Launches Seiko SLP850 2" Thermal Printer with Free Label Promotion
- Scientific Figure Releases Free Layout Template Libraries for Graphical Abstracts and Research Posters
- Permian Museum announces the addition of an Ancient Alien Artifacts photo gallery
- Philly Tailgates Announces Full 2026 Eagles Season Schedule, Opening With Back-to-back Events
- The Golden Jazz Fest Shuttle Returns for 2026
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
- Hollywood In Pixels Announces Honorees for The 9th Silver PIXel Awards
- New Research Finds a Good Deal Is All It Takes to Get Americans Booking a Last-Minute Vacation — and Most Already Have One on Their Mind
- GitKraken Introduces GitLens 19, Bringing Human and AI Workflows Together in One Workbench
- LĪNA Universal Balm Nominated for "Best Clean Skincare Product" at CertClean Beauty Awards
- Bronze Stevie Award Recognizes Satyadhar Joshi for AI Research and Public Policy Engagement
- synseer Nominated for Best Startup in 2026 Prix Galien USA Awards Following Record Breaking Applicant Pool
- Leading PDR Training Courses in Canada: Learn Paintless Dent Repair with PDR Academy & Tint Academy
- Move in this Fall! New Released Quick Move-In Townhomes at Heritage at South Brunswick with Limited-Time Incentives
- Rebecca L. Francis, Founder of the Rebecca Francis Team, Named to Lehigh Valley Business' LVB 300
- Crossroads4Hope Marks 25 Years Ensuring No One Faces Cancer Alone At its Inspiring Hope Gala
- Imagen Golf & Top 100 Coach Daniel Guest Voted Best Golf Instruction Firm of the Year 2026
- Q1 2026 Arizona Technology Industry Impact Report Recaps Advanced Manufacturing Growth, High-Value Jobs and Workforce Investment
- Former Prosecutor Opens Stegall Law in Summerville
- Vboost Celebrates 14 years of Automotive Viral Marketing
- M.C. Weeks, Inc. Marks 80 Years of Family Ownership and Brand Refresh
- Ignazio Arces Wins Stevie® Award for Maverick of the Year at the 2026 International Business Awards
- SMACK Fighting Championships Debuts a New Sports Concept in Philadelphia
- Tickeron Highlights AI Trading Agent Performance Across Multiple Market Sectors
- Stop Bleeding Cash on Mediocre Talent. Build a Powerhouse Remote Team Instead
- Crownlight Strategies® Announces Federal Trademark Registration