№ files_lp_4_process_2_62967
Press release detailing the FDA Breakthrough Device Designation granted to the ELF Test by Siemens Healthineers for noninvasive detection and prognostic assessment of advanced liver fibrosis and cirrhosis in patients with nonalcoholic fatty liver disease.
Year: 2023
Location: Tarrytown, NY, USA
Subject: Medical diagnostics, liver disease
Document type: Press release
Organization: Siemens Healthcare Diagnostics Inc.
Author: Kimberly Nissen
Target audience: Healthcare professionals, journalists
Regulatory status: FDA Breakthrough Device Designation
Test: Enhanced Liver Fibrosis (ELF™) Test
Biomarkers: Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), Tissue inhibitor of metalloproteinase 1 (TIMP-1)
Clinical relevance: Identification of advanced fibrosis and cirrhosis in NAFLD/NASH patients
Date issued: July 18, 2023
Associated guidelines: American Diabetes Association, American Association of Clinical Endocrinology, American Gastroenterological Association, American Association for the Study of Liver Diseases
Price: 8 / 10 USD
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