Non-invasive MRI for liver disorders receives expanded FDA clearance
Perspectum Diagnostics Ltd. received 510(k) clearance from the FDA for LiverMultiScan, a post-processing software device for MRI of the liver, which will expand its access to more patients with liver disorders who can benefit from non-invasive diagnostic aid, according to a press release.
With this FDA clearance, the device can now be used on scanners such as compatible Siemens and Philips MR systems, and will offer clinicians qualitative measures of the liver tissue to help with diagnosis of liver disease, according to the release.
“The development of standardized, robust methods for quantitative assessment of fatty liver disease is essential for both patients and physicians,” Mukesh Harisinghani, MD, abdominal imaging and interventional radiologist at Massachusetts General Hospital, said in the release. “LiverMultiScan is a useful radiological tool for clinical practice that will undoubtedly move the field forward and facilitate care of our patients with liver disease.”
The LiverMultiScan can be easily integrated into existing MR assessments and allows non-invasive and quantitative liver tissue characterization to quantify liver fat, T2 and iron-corrected T1 rapidly and accurately, per the release. The device enables clinicians to visualize heterogenous liver tissue and aid in clinical decision making, said the release. Currently, LiverMultiScan is being used in a multi-center randomized, control trial of 2,000 patients with non-alcoholic fatty liver disease (NAFLD).
“MR imaging is a cornerstone of the diagnostic pathways in neurology, musculoskeletal medicine and cardiology. We can now add liver disease to this list, taking us a step further on our journey towards establishing a replacement for more invasive diagnostic techniques for liver disease.” Rajarshi Banerjee, PhD, CEO of Perspectum Diagnostics, said. “Our research has shown that using LiverMultiScan results to help patients visualize their liver condition aids their understanding and engagement in their care and treatment.”
Disclosures: Banerjee is CEO of Perspectum Diagnostics. Healio Hepatology was unable to confirm any relevant financial disclosures for Harisinghani.