Trending...
- Sylvester Anthony III Introduces His Artist Journey with Debut Single "Cherish"
- Mister Omaha Tries The Turf At Lone Star Park
- Together We Thrive: Kingdom Life Health & Career Fair Unites Faith, Wellness and Opportunity
~ 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
- Rebecca Francis Team Ranks Among Top 1.5% of Teams and Agents Nationwide
- Ascent Solar Technologies (N A S D A Q: ASTI): Positioned at the Intersection of the New Space Economy, Defense Innovation and Next-Generation Energy
- Triple-Digit Growth, Stock Market Upgrade plus a Rapidly Expanding Specialty Healthcare Platform: Cardiff Lexington Corporation (Stock Symbol: CDIX)
- Morrisville & Cary Education Centers Honored with National Award
- AI-Powered Neuropsychiatry, FDA Regulatory Momentum, Commercial Ketamine Launch Position NRx Pharmaceuticals for Potential Breakout Growth in 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.
Filed Under: Business
0 Comments
Latest on The PennZone
- Arizona Christian Homeschools Launches Statewide Directory
- LKPFM Corporation Canada the importance
- Sexually Abused in a Psychiatric Hospital or Psychiatrist's or Psychologist's Office? CCHR Urges Survivors to Reach Out to It
- Ten Ten Ten Announces Free Value-Based Care Playbook for Independent Primary Care Practices
- Senco Home Services Expands Residential Construction Services
- Ricci's Painting & Contracting Expands Home Transformation Services
- United Way and Community Partners Launch Relief Fund to Support Victims of the Six-Alarm Fire in Allentown
- Sylvester Anthony III Introduces His Artist Journey with Debut Single "Cherish"
- Boston Industrial Solutions Introduces High-Performance Primer for Bonding Liquid Silicone to Epoxy
- Together We Thrive: Kingdom Life Health & Career Fair Unites Faith, Wellness and Opportunity
- Healthcare Leaders Publish New Integrated Behavioral Healthcare Guide, Led by Doctors of Behavioral Health
- Verbica Challenges Panetta to a Televised Debate on the Issues
- Grace Montessori School Raises $115,000 for Student Scholarships and Enhanced Programming
- Salt Lake City Families Turn to Private Autopsy Services for Faster Answers After Unexpected Loss
- K2 Integrity's U.S. and EMEA Teams Again Recognized in Chambers and Partners 2026 Guides
- Connecta Satellite Solutions Ready to Support Emergency Communications Following the Venezuela Earthquake
- Rare 1933 Harold Weston painting will be auctioned to benefit the Keene Valley Library
- $20 Million Revenue Target, Accelerating Growth, 7% Of Outstanding Shares Retired, Clear Path Toward Profitability: VSee Health, Inc N A S D A Q: VSEE
- HomeCentris Home Health Achieves 5-Star CMS Rating
- Adsoptia Launches AI-Powered Optimization Platform for a New Era of Autonomous Marketing Decisions