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Intended use: HepaFatSmart is intended for the quantitative measurement of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and steatosis grading. HepaFatSmart is an application that is used for the non-invasive evaluation of liver tissue by utilising magnetic resonance images to evaluate the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver. Indications for use: Support clinical diagnoses in individuals with confirmed or suspected fatty liver disease; Support the subsequent clinical decision making processes for patients under management for fatty liver related disease or metabolic syndromes; Aid in the assessment and screening of living donors for liver transplant. Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver fat content, the subsequent clinical decision making processes for the management of fatty liver related diseases, metabolic syndromes, liver donor screening and lifestyle change. HepaFatSmart can be used to analyse the MRI images of patients of all populations independent of age and gender, with suspected clinical conditions related to the level of liver fat.

HepaFatSmart is an SaMD designed to automatically analyse magnetic resonance imaging (MRI) datasets for quantitative assessment of a patient's liver fat, in form of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), and steatosis grade. It is an Al assisted, automated version of HepaFat-Scan (another SaMD of Resonance Health). To carry out an analysis, the user simply uploads DICOM images to FAST, Resonance Health's secured user portal and job management system. No other user input is required for the analysis thereby minimising the impact of human error on obtained results. HepaFatSmart requires DICOM images as input data that have been acquired according to the HepaFatSmart (same as HepaFat-Scan) protocol.

LiverSmart is indicated to: For Liver Iron Concentration 1. measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; 2. monitor liver iron burden in transfusion dependents and patients with sickle cell disease receiving blood transfusions: 3. aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox. For Liver Fat Assessment 1. assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease. When interpreted by a trained physician, the results can be used to: 2. monitor liver fat content in patients undergoing weight loss management; 3. aid in the assessment and screening of living donors for liver transplant.

LiverSmart is software that utilizes two existing FDA cleared devices, HepaFat-AI (K201039) and FerriSmart (K182218) and combines their respective results into a singular consolidated multiparametric 'LiverSmart' report. LiverSmart automatically sorts and sends magnetic resonance imaging (MRI) datasets to each of the existing HepaFat-AI and FerriSmart devices and then receives results from those devices to generate a summary report which combines the HepaFat-AI results (an estimate of the patient's volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), steatosis grade), and the FerriSmat result (an estimate of the patient's liver iron concentration (LIC)). To conduct analysis, the user simply uploads a single zipped folder containing HepaFat-AI and FerriSmart DICOM images, acquired in accordance with their respective acquisition protocols, to the LiverSmart software. No user input is required for the analysis thereby minimising the impact of human error. The LiverSmart software requires image input data that has been acquired in accordance with the existing and now well established HepaFat-AI (K201039) and FerriSmart (K182218) imaging protocols. LiverSmart has two new components that are in addition to the existing components of HepaFat-AI and FerriSmart, namely a: - (i) Data Preparation Module; and - (ii) Report Generation Module The rest of the components for LiverSmart are the existing components of the FDA cleared HepaFat-AI and FerriSmart devices, as follows: For HepaFat-AI: - (i) Magnetic Resonance Imaging Protocol - (ii) HepaFat-AI Analysis Software - (iii) Volumetric Liver Fat Fraction Measurement - (iv) Proton Density Fat Fraction Measurement - (v) Steatosis Grade Measurement For FerriSmart: - (i) Magnetic Resonance Imaging Protocol - (ii) FerriSmart Analysis Software - (iii) Liver Iron Concentration Measurement The above HepaFat-AI and FerriSmart components are the same as previously provided to the FDA as the time HepaFat-AI and FerriSmart regulatory clearances were sought (and subsequently obtained).

HepaFat-AI is indicated to: Assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease; When interpreted by a trained physician, the results can be used to monitor liver fat content in patients undergoing weight loss management and can be used to aid in the assessment and screening of living donors for liver transplant.

The HepaFat-AI Analysis System is a software platform designed to automatically analyse magnetic resonance imaging (MRI) datasets to generate an estimate of the patient's volumetric liver fat fraction (VLFF). To carry out an analysis, the user simply uploads raw DICOM images to the HepaFat-AI Analysis System. No user input is required for the analysis thus minimising the impact of human error on obtained results. The HepaFat-AI system requires image input data that have been acquired according to the HepaFat-Scan protocol. The key components for the HepaFat-AI Analysis System for volumetric liver fat fraction measurement are: Magnetic Resonance Imaging Protocol: The use of a specific magnetic resonance imaging protocol for acquisition of the raw image data. The imaging protocol is critical to ensure the quality of the end results. Its adherence is verified by the IOC Module, an automated algorithm that checks the correctness of each parameter in the protocol. HepaFat-AI Analysis Software: Custom-designed image analysis software performing the Alpha measurement and anomaly detection based on Artificial Intelligence (AI) technology. It is composed of 2 convolutional neural networks. The primary network is for the prediction of Alpha and a secondary network is for anomaly detection. This element is considered the medical device for a regulatory perspective. Following the training of the AI tool, the system is 'locked-down' for final validation prior to release in commercial use to ensure reproducibility of the results. Volumetric Liver Fat Fraction Measurement: An additional software module (algorithmic) that incorporates a conversion lookup table relating Alpha to volumetric liver fat fraction (VLFF) is added to allow production of a volumetric liver fat fraction report. Proton Density Fat Fraction Measurement: An additional software module (algorithmic) that incorporates a conversion lookup table relating VLFF to proton density fat fraction (PDFF) is added to allow production of a proton density fat fraction report. Steatosis Grade Measurement: An additional software module (algorithmic) that incorporates a conversion lookup table relating VLFF to the steatosis grade. The output of the HepaFat-AI Analysis System is an automated report. This report is populated with the information stored in the DICOM header of the MRI images, and the analysis result Alpha converted into a VLFF value and a steatosis grade, associated confidence interval and normal range. The report also contains pictures of the 3 TEs of the analysed slice. This is essential for the radiologist to check if the image analysed is a liver image, and the result provided is consistent with other relevant clinical results.

FerriSmart is indicated to: · measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; · monitor liver iron burden in transfusion dependent thalassemia patients with sickle cell disease receiving blood transfusions: • aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.

FerriSmart is a stand-alone software application that automatically analyses multi-slice, spin-echo MRI data sets encompassing the abdomen to determine the signal decay rate (R>) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo. The software application is a measuring medical device intended to be hosted either in a cloudbased or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients. The key components of FerriSmart are: - Specific Magnetic Resonance Imaging Protocol: Use of a specific magnetic resonance imaging protocol for acquisition of the raw image data. The imaging protocol is critical to ensure the quality of the end results. Its adherence is verified by the IQC Module, an automated algorithm that checks the correctness of the parameters of the data acquisition protocol. - FerriSmart AI Analysis Software: Custom-designed image analysis software performing the R2 measurement based on AI (Artificial Intelligence) technology. - An additional software module (algorithmic) that Liver Iron Measurement: incorporates a calibration curve relating R2 to liver iron concentration (LIC) is added to allow production of a liver iron concentration report. The result report provides the patient's average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management.

HepaFat-Scan is a software device intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver. When interpreted by a trained physician, the results provide information that can aid in diagnosis.

Standalone software application to facilitate the import visualization of multi-slice, gradient-echo MRI encompassing the abdomen, with functionality independent of the MRI equipment, to provide objective and reproducible determination of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.

The FerriScan R2-MRI Analysis System is intended to measure liver iron concentration to aid in the identification and monitoring of non-transfusiondependent thalassemia patients receiving therapy with deferasirox.

The FerriScan R2-MRI Analysis System is a post-processing software tool that measures liver iron concentration based on the proton transverse relaxation rate (R2) of MRI images. R2 values are converted to liver iron concentration measurements using a calibration curve.

The MRI-Q System is intended to provide additional processing of images for the analysis of multi-slice gradient echo MRI data sets of cardiac tissue to quantify the signal decay rate (R2*) and time (T2*). The MRI-Q System is a software device that provides quantitative analysis of magnetic resonance image signal decay parameters in cardiac tissue. The device contains an image viewer for importing DICOM images, browsing through datasets and performing quantitative region of interest analysis. The software device has capability to measure the signal decay rate (R2*) and time (T2*) in heart tissue.

Stand alone software package used to facilitate the import, visualization and analysis of multi-slice gradient echo MRI data sets encompassing cardiac tissue, to quantify the signal decay rate (R2*) and time (T2*).