Sonic Incytes Receives FDA 510(k) Clearance of AI Powered Features for Velacur™️ Liver Ultrasound
May 4, 2023
Sonic Incytes is pleased to announce they have received Food and Drug Administration (FDA) clearance for new Organ Guide and Wave Quality Detector features for Velacur™️, the Company’s liver diagnostic tool. These new artificial intelligence and machine learning (AI-ML)-based tools will improve the accuracy and performance of the device and enable less experienced medical personnel to conduct liver scans with similar accuracy and proficiency as an experienced sonographer.
Velacur is an ultrasound solution used in-office to quantify stiffness (elasticity) and attenuation (fat) in the liver, both critical measurements in the diagnosis of non-alcoholic fatty liver disease (NAFLD) and the more severe form called non-alcoholic steatohepatitis (NASH) which can lead to liver cancer, cirrhosis, and death.
The Organ Guide integrates proprietary AI-ML technology that accurately identifies and highlights the liver tissue on the ultrasound image with a color overlay, making identification of the liver as easy as pressing a button, and overcoming one of the challenges of conventional ultrasound. The AI-ML-based Wave Quality Detector, evaluates the quantity and strength of shear waves present in the liver resulting in higher quality scans and overall improved accuracy.
“FDA clearance and launch of our new AI-ML technology is a significant achievement and will have a substantial impact on both new and existing users,” said Barry Allen, President and CEO of Sonic Incytes. “The addition of these innovations enhances our product and confirms that affordable, accessible, and accurate measurements of liver health can be performed in a doctor’s office by any medical professional.” Allen added, “With the approval of NASH drugs on the horizon, the need for these types of tools is greater than ever.”
Sonic Incytes will be demonstrating Velacur with these new features (Booth 4535) at Digestive Disease Week (DDW), an international conference that highlights latest advances in Gastroenterology, May 7th through 9th in Chicago, IL.
About Fatty Liver Disease
Non-alcoholic fatty liver disease (NAFLD), including non-alcoholic hepatic steatosis (NASH), is a global health crisis affecting 30% of the population and is often associated with obesity, diabetes and metabolic syndrome. Approximately 20% of those with NAFLD progress to non-alcoholic steatohepatitis (NASH), which can cause inflammation, liver cell damage, fibrosis and ultimately cirrhosis. If detected early, the condition can be reversed.
Velacur is the first liver assessment tool with 3D S-WAVE technology to provide real-time assessments of liver tissue stiffness and attenuation. Velacur combines elements of magnetic resonance elastography, shear wave ultrasound, and liver visualization to deliver accurate measurements in a point-of-care setting. Low cost and portable, Velacur can be administered by a trained medical assistant during a typical office visit.
About Sonic Incytes
Sonic Incytes is dedicated to developing accessible solutions that provide health insights to enhance patient care. In response to the growing prevalence of chronic liver disease, Sonic Incytes is determined to establish liver health as a new vital sign. Their novel point-of-care ultrasound-based imaging solution, Velacur, is redefining the standard of care in quantifying liver tissue stiffness and attenuation to aid in the clinical management of patients with chronic liver disease.