Trending...
- Proper Sky Named to the 2026 MSP 501
- Woodforest Acceptance Solutions and AlpacaBOSS Launch Partnership
- New "Lakeside Picnic Ride" Package in Japan's Lake Chuzenji region of Nikko: July 1- November 30, 2026
~ 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
- Sara Abbas Receives "Eniochos" Charioteer Award at 2026 Who is Who International Awards
- Detained at 95: South Korea's Prosecution of a Religious Leader Draws International Alarm
- CCHR: DOJ Takedown Exposes Over $220 Million Defrauded in Behavioral Mental Health Fraud Schemes
- Exeter Smiles Encourages Reading Families to Start Teen Braces This Summer
- ARC Technologies Announces Corporate Asset Sale of buildings, inventory and IP patents
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
- UK Financial Ltd. Opens Test-Phase Maya 3 Liquidity Pool on Uniswap with DEX Screener Visibility for Market-Smoothing Ahead of CATEX Exchange Launch
- From DECA Finalist to Translational Scientist: Roohid Parast on Business Training in Biopharma
- Wagga Trucks set to expand to the Canberra Region as authorised dealer for Volvo, UD & Mack along with Freighter Group Trailers
- June Employment Report Reveals Hidden Weakness Beneath Lower Unemployment
- Exeter Smiles Encourages Families to Start Teen Braces This Summer
- The Hue Society Expands Roster for the 2026 Wine and Culture Fest
- Kasinohai Audit: Most Slots Could Be Affected by Finland's Draft Gambling Rules
- Why More Phoenix Families Are Turning to Private Autopsy Services for Answers
- Fig Lehigh Valley Celebrates 50th Edition With Summer Launch Party at the Americus Hotel
- Make America French Again Launches National Campaign
- RAS AP Consulting Expands AP Governance & Automation Practice and Named Finalist for Heidelberg Materials SAP Vendor & Customer Data Project
- New Children's Book Teaches Kids the Lesson Its Author Spent a Career Learning: Your Worth Doesn't Need Permission
- Proper Sky Named to the 2026 MSP 501
- 100+ Episodes In, Liftoff with Keith Newman Tells Founders to Stop Publishing More
- Vierra Communities Adds Operations of Two Skilled Nursing Facilities in the DC Metro Area
- Slotozilla Introduces a Centralized Resource for World Cup Bonus Offers
- Webinar Announcement: Built for Trust: Latitude's 0 to 1 Compliance Playbook for Modern Cross-Border Payments
- OneVizion Names AI Leader Matthew Kirk as Chief Operating Officer to Drive Governed AI Across Telecom and Electric Utilities
- Dentists launch independent platform to help practices choose the right technology
- Contracting Resources Group Recognized by The Daily Record as a 2026 In the Lead: Best Women-Owned Businesses Honoree