FDA Clears Sonic DL™ For Cardiac MRI Scans - Knobbe Medical

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.