Resonance Health Granted FDA’s 510(k) Clearance for LiverSmart

Australia’s Resonance Health has received 510(k) marketing clearance from the FDA for its LiverSmart software for analysis of magnetic resonance imaging (MRI) scans of the liver.

The artificial intelligence-based software, which assesses the MRI scans to determine liver-iron and liver-fat, also enables screening of patients with elevated levels of ferritin, a blood protein that stores iron and releases it in a controlled fashion.

The software combines two of the company’s previously FDA-cleared software products, FerriSmart and HepaFat-AI, for use in a single MRI session.