www.fdanews.com/articles/201112-perspectums-liver-cancer-mri-solution-earns-510k-clearance
Perspectum’s Liver Cancer MRI Solution Earns 510(k) Clearance
February 1, 2021
The FDA has granted 510(k) clearance for Perspectum’s Hepatica, a magnetic resonance imaging (MRI) oncology support tool for liver cancer evaluations.
Oxford, UK-based Perspectum is partnered with the University of Oxford to develop tools for quantitative measurement of liver, gallbladder and pancreatic diseases, including precancerous and cancerous states.
Hepatica generates a liver health assessment and identifies high-risk patients using noninvasive MRI that, according to the company, saves more than 20 minutes of pre-operative radiology time per case. The imaging tool produces a patient-friendly report using a cloud-based service.