Home PageFOR IMMEDIATE RELEASE
MGC Diagnostics Corporation Receives 510K Substantial Equivalence Determination for Ascent™ Cardiorespiratory Diagnostic Software
St. Paul, MN, October 17, 2024 – MGC Diagnostics Corporation, a global medical technology company dedicated to cardiorespiratory diagnostic solutions, is pleased to announce that it has received notification of 510K Substantial Equivalence Determination from the U.S. Food and Drug Administration (FDA) for its Ascent™ cardiorespiratory diagnostic software. Ascent™ is now available for both Pulmonary Function Testing (PFT) and Cardiopulmonary Exercise Testing (CPET).
Ascent™ is a comprehensive software platform designed to streamline cardiorespiratory diagnostic testing and interpretation workflow. The software seamlessly integrates with MGC Diagnostic systems, providing real-time data capture and analysis. Ascent™ offers a wide range of advanced features, including:
- Intuitive user interface: The software features a modern and intuitive interface that is easy to learn, use, and customize.
- Comprehensive reporting: Ascent™ generates comprehensive reports that can be tailored to meet the specific needs of each organization.
- Advanced analysis tools: The software includes a variety of advanced analysis tools, such as the ATS/ ERS grading scorecards, automated PFT and CPET interpretation, and exercise prescription.
“We are thrilled to receive the notification of substantial equivalence determination for Ascent™,” said Todd M. Austin, President at MGC Diagnostics Corporation. “This software platform was designed from the ground up and represents a significant advancement in cardiorespiratory diagnostics. Offering a single, integrated solution for both PFT and CPET enables MGCD to provide our customers with a modern and more efficient way to assess patient respiratory and cardiovascular function.”
About MGC Diagnostics Corporation
MGC Diagnostics Corporation is a global medical technology company dedicated to cardiorespiratory health solutions. The company, with facilities in Belgium, Germany, France, Italy and Australia, develops, manufactures and markets non-invasive diagnostic systems. This portfolio of products provides solutions for disease detection, integrated care, and wellness across the spectrum of cardiorespiratory healthcare. The Company’s products are sold internationally through distributors and, in the United States, France, Belgium and Australia, primarily through a direct sales force targeting heart and lung specialists located in hospitals, university based medical centers, medical clinics, physicians’ offices, pharmaceutical companies, medical device manufacturers, and clinical research organizations (CROs). On December 28, 2022, MGC Diagnostics was acquired by CAIRE Inc., a leading global manufacturer of oxygen therapy and on-site generation systems. For more information, please contact MGC Diagnostics Corporation at 800.950.5597or visit mgcdiagnostics.com.