LiverMultiScan™ Receives FDA 510(k) Clearance for Version 2 of Medical Device
- November 27, 2017
We are delighted to announce that LiverMultiScan™ has received FDA 510(k) clearance for the next release of the software. Read the full press release below:
FDA Clearance For Perspectum Diagnostics’ LiverMultiScan™ Means More Patients Can Benefit From Access To State-Of-The-Art Non-Invasive Diagnostic Aid For Liver Disorders.
- More patients can benefit from non-invasive assessment of the liver through expanded compatibility with MRI systems
- LiverMultiScan comprehensive analysis allows the clinician to visualize heterogeneous liver tissue and assist in clinical decision-making
- LiverMultiScanprovides non-invasive quantitative assessment of the liver, using state-of-the-art multiparametric mapping techniques, suitable to aid diagnosis of patients with suspected liver disorders
Oxford, United Kingdom, Monday November 27, 2017: Perspectum Diagnostics Ltd, a global leader in the development of medical image analysis technologies, announced today at the Radiological Society of North America (RSNA) conference that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for LiverMultiScan – a post-processing software device for magnetic resonance imaging (MRI) of the liver, delivered through a cloud-based service. This latest clearance means that this unique technology can now be used on a wider range of scanners, including compatible Siemens and Philips MR systems, and provide clinicians with standardized, quantitative measures of the liver tissue to assist with diagnosis of liver disease.
LiverMultiScan enables non-invasive and quantitative liver tissue characterization to quickly and accurately quantify liver fat, as well as T2* and iron-corrected T1 which are correlates for iron and fibro-inflammatory levels respectively. It is a rapid and scalable technology that can be seamlessly integrated into existing MR examinations, without the need for contrast agent.
Professor Mukesh Harisinghani, Abdominal Imaging and Interventional Radiologist at Massachusetts General Hospital, remarked, “The development of standardized, robust methods for quantitative assessment of fatty liver disease is essential for both patients and physicians. 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.”
Non-alcoholic fatty liver disease (NAFLD) currently affects more than 30% of people in the U.S. and 10% of those in the U.K. If left untreated, it can lead to cirrhosis and liver failure. NAFLD prevalence is expected to increase, driven by rising levels of obesity and representing a significant area of unmet need in global healthcare. This trend is a growing concern and strategies to prevent, detect and treat NAFLD are a high priority for health systems.
“Liver disease is a huge unmet need,” said Dr Rajarshi Banerjee, CEO, Perspectum Diagnostics. “Drug development is hampered by the lack of ways to determine efficacy and outcomes, and to find the patients who would benefit from the new drugs. 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.” He adds, “Patients are at the heart of our innovation. 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. As we move towards more patient-centered innovation, we’re proud to be leading in this area.”
Professor Hildo J. Lamb, Professor of Radiology at Leiden University Medical Center, where LiverMultiScanis currently being used as part of a 2,000-patient multi-center randomized control trial in NAFLD, said: “Radiology is moving into a new era of quantitative imaging. LiverMultiScan provides a user-friendly platform for MR image acquisition and analysis. Quantitative assessment of fatty liver disease is of paramount importance to fight obesity-related disease.”
About Perspectum Diagnostics
Perspectum Diagnostics Ltd combines the power of digital imaging technologies and innovative software. We empower patients and the medical community through greater understanding of liver disease, enabling earlier diagnosis and targeted treatment.
LiverMultiScan is 510(k) cleared in the U.S. and CE marked in Europe. LiverMultiScan may not be commercially available in all countries. Due to regulatory reasons, its future availability cannot be guaranteed. For further details for more information, visit https://perspectum-diagnostics.com/.
- Banerjee, R. et al. (2014). Journal Hepatol 60:69–77.
- Pavlides, M. et al. (2016). J Hepatol, 64:308-315.
- Pavlides, M. et al. (2017). Multi-parametric magnetic resonance imaging for the assessment of non-alcoholic fatty liver disease severity. Liver International, 1-9.
- McKay et al. (2016). Hepatology 64(S1):811-1050