On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™. GE HealthCare reports that Sonic DL™ is a deep learning-based technology intended to capture cardiac MRI images within a single heartbeat.
GE HealthCare states that current cardiovascular MRI systems require prolonged breath holding because several heartbeats are required to capture acceptable imaging. According to the announcement, Sonic DL™ introduces an AI deep learning-based technology into the cardiac MRI method and produces results 12 times faster than the standard procedures.
Jie Xue, President & CEO and Global MR of GE HealthCare, stated:
[Sonic DL] greatly expands patient access and improves diagnostic value for patients who need it the most but previously couldn’t be scanned successfully…. Our industry-leading deep learning technology, AIR Recon DL, has already benefited more than 10 million patients. We expect Sonic DL to further extend the lead of GE HealthCare in leveraging AI to advance healthcare and benefit patients around the world.
According to a market model by GlobalData, GE HealthCare continues to expand its AI-enabled solutions portfolio and is estimated to occupy a 25% share of the global MRI market. Another report forecasts that the global MRI market will be over $9 Billion by 2030.
The press release from GE HealthCare may be found here.
Tags
510(k), 510(k) Clearance, artificial intelligence, GE Healthcare, mri
By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.
