Perspectum Diagnostics wins FDA 510(k) for LiverMultiscan MR device

 

Perspectum Diagnostics said it won FDA 510(k) clearance for its LiverMultiscan MR imaging device designed to detect early liver disease.

The LiverMultiScan uses quantitative MR methods and provides a highly detailed map of the whole liver for clinicians to identify regions of disease, the U.K.-based company said.

Perspectum Diagnostics said the device is currently used in clinical research programs targeting new therapies to treat liver disease.

“This has been a very important year for Perspectum. We have expanded our global footprint with installations of LiverMultiScan in many new treatment and research centers around the world and we continue to make great progress in our strategy for global expansion. Our successful financing and FDA clearance represent strong validation of our technology, and we continue to be very pleased that leading investors recognize the potential of our business model to improve patient care and play an essential role in clinical research to develop new therapies to treat liver disease,” CEO Dr. Rajarshi Banerjee said in a press release.

Perspectum Diagnostics said as many as 6 patients an hour can be tested using one of the MR systems with a reported 95-97% success rate.

“LiverMultiScan is a novel non-invasive imaging technology with the potential to dramatically change the way we approach diagnosis of liver diseases such as NAFLD. Recent published data suggest that this modality can rapidly differentiate normal liver from fibrotic NASH and then accurately predict outcomes based on the liver, inflammation, fibrosis score. Further studies are warranted to confirm these findings, but we are excited about the possibilities this imaging modality offers for the future in NASH diagnostics,” trial investigator Colonel Stephen Harrison of the San Antonio Military Medical Centre said in prepared remarks.

The company said the approval has cleared it for a slated formal launch at the American Association for the Study of Liver Disease’s annual meeting this month.

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