A new clearance from the FDA allows the MGC Diagnostics Ascent cardiorespiratory diagnostic software to be used for both pulmonary function testing (PFT) and cardiopulmonary exercise testing (CPET), according to the company.

RT’s Three Key Takeaways

  1. MGC Diagnostics Corporation’s Ascent cardiorespiratory diagnostic software has received 510(k) clearance from the US FDA, making it available for pulmonary function testing (PFT) and cardiopulmonary exercise testing (CPET).
  2. The Ascent platform integrates with MGC systems, capturing and analyzing real-time data with features such as an intuitive interface, customizable reports, and advanced tools like ATS/ERS grading and automated interpretations.
  3. According to President Todd M. Austin, Ascent offers a unified, efficient solution for respiratory and cardiovascular diagnostics, enhancing workflow for healthcare providers.

MGC Diagnostics Corp has received notification of 510K Substantial Equivalence Determination from the US FDA for its Ascent cardiorespiratory diagnostic software. Ascent is now available for both pulmonary function testing (PFT) and cardiopulmonary exercise testing (CPET), according to the company.

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.”