HealthFLD AI Platform for Fatty Liver Detection Gains FDA Approval

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Nanox provides artificial intelligence-informed (AI) medical imaging services that enable the identification of those living with undetected chronic diseases.

Health & Medicine

HealthFLD AI Platform for
Fatty Liver Detection
Gains FDA Approval

Nanox provides artificial intelligence-informed
(AI) medical imaging services that enable the
identification of those living with undetected
chronicdiseases. In February 2024, Nanox
received FDA approval for the use of its fully
automatedHealthFLD AI software in analyzing
liver attenuationfromCT scans among the
general population.

This is important, as some 24 percent of US adults have
MASLD (formerlynon-alcoholicfatty liver disease), which is
a metabolic disease connectedwith obesity. Having MASLD
increases the risk of severe liver issues such as cirrhosis, as
well as cardiovascular disease. It’s asymptomaticuntil it
progressesto the advanced liver fibrosis stage, with
invasive and expensive liver biopsy as the standard
diagnostic.

The HealthFLD solution supportsearly diagnosis of fatty liver through
a qualitative and quantitativeanalysis of routine abdomen and chest
CT scans amongpatients in the 18 to 75 age range. Reliable,
automated,non-invasive, and scalable to large patient populations,
this AI assessment approach is poised to significantly improve health
outcomes.

Similar to HealthFLD AI Platform for Fatty Liver Detection Gains FDA Approval

RESULTS A total of 12 113 patients (mean [SD] age, 64.8 (11.0) years for the PCI group and 65.6[9.7] years for the CABG group; 5084 (72.5%) male for the PCI group and 4229 (82.9%) malefor the PCI group) were propensity score matched on 30 baseline characteristics: 2397 patients undergoing PCI and 2397 patients undergoing CABG. The median follow-up was 5.2 years (interquartile range, 5.0-5.3). Patients who received PCI had significantly higher rates of mortality (hazard ratio [HR], 1.6; 95% CI, 1.3-1.7), death from cardiovascular disease (HR 1.4,95% CI, 1.1-1.6), MACE (HR, 2.0; 95% CI, 1.9-2.2), subsequent revascularization (HR, 3.7; 95% CI, 3.2-4.3), and hospitalization for MI (HR, 3.2; 95% CI, 2.6-3.8) and heart failure (HR, 1.5;95% CI, 1.3-1.6) compared with matched patients who underwent CABG.

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The aim of this study is to evaluate the results of liver examination by ultrasound in Najran patients during the period Dec 2011- Dec 2012, specifically to discover the rate of incidence of fatty liver and its relationship to risk factors. This is a retrospective, descriptive and quantitative case series using data collected from King Khalid hospital in Najran during the period Dec 2011- Dec 2012, where 957 patients had undergone ultrasound examination for different abdominal diseases. Data of this study was collected using a check list from the PACS (picture archive and communicating system) and the results were analyzed by using SPSS computer system. Data for a total of 957 patients who had completed abdominal ultrasound were collected. 319 were found to have fatty liver as diagnosed by ultrasound. The mean age of the study group was (49.6 ± 14.1), the mean weight was (78± 6.12), and an elevated level of ALT (alanine aminotransferase ), AST (aspartate aminotransferase) was detected in 55.7 % and 43.2% respectively . A BMI (Body mass index) > 25kg/m2 was detected in 80 % of the patient. The prevalence of NAFLD (non alcoholic fatty liver disease) was 33.3 % and it was more common in females (178, 55.4%) than in males (141, 44.1%). It is highest in the age group 40-60 years old. Diabetes was present in 24.1 % (77 patients with high fasting glucose), obesity in 45.7% (147 patients). Of the all patients, high cholesterol was present in 23, 7 % of the total. The prevalence of fatty liver in Najran patients is high. It is more common in the female than male. Obesity and diabetes are the common risk factors associated with fatty liver disease.

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NASH stands for Non-Alcoholic Steato-Hepatitis. It is a type of non-alcoholic fatty liver disease (NAFLD). It is a condition where excess fat is stored in the liver, not caused by heavy alcohol use. NASH is more severe as the excess fat eventually causes inflammation of the liver. This leads to fibrosis or scarring of the liver. In the long run, NASH can lead to cirrhosis or liver cancer. It is a common yet silent disease that is difficult to diagnose, with no approved treatment available. By the year 2020, it is estimated that NASH will be the leading cause of liver transplantation in the US.

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HealthFLD AI Platform for Fatty Liver Detection Gains FDA Approval

1. HealthFLD AI Platform for Fatty Liver Detection Gains FDA Approval

2. Nanox provides artificial intelligence-informed (AI) medical imaging services that enable the identification of those living with undetected chronicdiseases. In February 2024, Nanox received FDA approval for the use of its fully automatedHealthFLD AI software in analyzing liver attenuationfromCT scans among the general population.

3. This is important, as some 24 percent of US adults have MASLD (formerlynon-alcoholicfatty liver disease), which is a metabolic disease connectedwith obesity. Having MASLD increases the risk of severe liver issues such as cirrhosis, as well as cardiovascular disease. It’s asymptomaticuntil it progressesto the advanced liver fibrosis stage, with invasive and expensive liver biopsy as the standard diagnostic.

4. The HealthFLD solution supportsearly diagnosis of fatty liver through a qualitative and quantitativeanalysis of routine abdomen and chest CT scans amongpatients in the 18 to 75 age range. Reliable, automated,non-invasive, and scalable to large patient populations, this AI assessment approach is poised to significantly improve health outcomes.

HealthFLD AI Platform for Fatty Liver Detection Gains FDA Approval

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