FDA Clears Arterys’ AI Mapping and Quantification Tools

Arterys has received U.S. Food and Drug Administration (FDA) clearance for its artificial intelligence-powered mapping and quantification tools.

The FDA green light—the company’s eighth—was bestowed upon Arterys’ modules for T1 mapping and T2 quantification. The T1 mapping tool, which also calculates extracellular volume fraction (ECV), looks for variations in the heart muscle’s tissue. Those findings can then be used to diagnose conditions like myocardial inflammation, fibrosis and hypertrophy, while the ECV calculations measure the empty space in the tissue that may also play host to certain myocardial diseases. T2 quantification, meanwhile, provides another characterization of the tissue of the heart muscle, helping physicians assess the severity of a case of myocardial infarction and detect swelling in patients with the condition.

These now-cleared modules offer a dedicated workflow for T1 and ECV, and T2 quantification, including multiple and global ROIs, and a graphical display of curves that provides users with intuitive, simple calculations for tissue characterization.

“With the addition of our new modules, we are able to accommodate a wide variety of users from community hospitals/physician centers to larger research centers and even pediatrics,” said Michelle Buekes, product manager, Cardio AI at Arterys. “We are very excited to continue to work with our customers and partners to build upon and improve our product to meet the needs of an evolving and growing field.”

In addition to the FDA clearance, Arterys announced several new modules to Cardio AI, a comprehensive, cloud-based post-processing solution that leverages AI and deep learning to provide extremely accurate, automated, fast, repeatable analysis of cardiac MRI images. 
 
The latest Cardio AI enhancements provide physicians with additional tools to remove redundant work and tedious editing to analyze Cardiac MRI images. These new modules make it easier for physicians to manage the increasing demand and provide consistent diagnostic decisions more efficiently. The latest modules include:

• Strain + AIPowered by 4D Flow — Incorporates a deep learning myocardial velocity and strain model that eliminates the need for time-consuming contour editing to obtain reliable strain results (available for research only).
• Atrial Volumes — Allows physicians to easily quantify volumes for both left and right atria in cardiac MRI images to aid in the diagnostic process.
• Wall Thickness — Provides automatic wall thickness measurements critical to the diagnosis process.

 
“Cardio AI is an integral part of our image interpretation and patient management,” said Ali B Syed, M.D., of Stanford School of Medicine, Department of Radiology. “It significantly reduces the time necessary to generate useful information from our imaging. What used to take 30 minutes or more is now done, in many cases, before the patient is even off of the MRI table. It has also accelerated our adoption of techniques like T1 mapping and quantitative delayed enhancement because it dramatically reduces the effort to report these values.”  

“Cardio AI has been an invaluable tool in our practice to allow us faster processing of complex cardiac MR examinations with automated contouring not only for function but also tissue characterization saving us minutes of processing time on every single exam,” said Melany B. Atkins, M.D., Division Chief, Body/Cardiovascular Imaging at Inova Fairfax Hospital. “Rapid processing of 4D Flow affords us the ability to evaluate complex congenital heart disease nearly real-time.” 
  
Arterys is the world’s first internet platform for medical imaging. Its objective is to transform healthcare by transforming radiology. The Arterys platform is 100 percent web-based, AI-powered, and FDA-cleared, unlocking simple clinical solutions.