Israeli AI leader DiA receives FDA clearance for ultrasound solutions

The addition of two new FDA clearances to DiA's LVivo toolbox reflects changes in the MedTech industry, with ultrasounds and AI-based analysis solutions becoming more valued by healthcare workers.

DiA’s LVivo RV uses AI to immediately detect signs of right ventricle dysfunction. (photo credit: DIA IMAGING ANALYSIS)
DiA’s LVivo RV uses AI to immediately detect signs of right ventricle dysfunction.
(photo credit: DIA IMAGING ANALYSIS)
Israel-based artificial intelligence leader DiA Imaging Analysis announced Thursday that it has received clearance from the US Food and Drug Administration (FDA) as well as a European CE mark for two new AI-powered ultrasound solutions to help aid in the ongoing battle against COVID-19.
The two new products are the LVivo RV, the first automated analysis of the right ventricle of the heart based on artificial intelligence (AI), and the LVivo Bladder, an AI-powered solution to give an automated measurement of bladder volume using ultrasound.
This announcement is very significant with regard to new developments in the fight against the coronavirus, as recent studies have shown a link between COVID-19 mortality and right-ventricle heart failure. According to a study at Mount Sinai Morningside Hospital, 31% of patients hospitalized with COVID-19 had right ventricle failure, and 41% of this subset who died had signs of right ventricle dilation or enlargement.
“The RV has always been very difficult to evaluate, due to its unique structure and location,” said Dr. Anthony M. Demaria, a leading cardiologist at University of California San Diego Medical Center and a co-investigator of the multi-center study for LVivo RV.
“This is further compounded by the complexity of the analysis itself, which relies on a combination of manual calculations and visual user input. LVivo RV is a welcome and very useful addition to clinicians’ toolbox for more quickly and effectively monitoring the right ventricle.”
Through a combination of advancing pattern recognition, machine learning and deep learning algorithms, LVivo RV can automatically run a rapid and accurate 2D ultrasound analysis of the right ventricle’s size and function to detect and monitor signs of right ventricle failure.

THE PRODUCT represents the next step in DiA’s flagship LVivo AI platforms by providing a faster and more accurate analysis of ultrasound data.
The company, which is one of the leaders in the AI field with six FDA-cleared products, already received a grant from the Israel Innovation Authority for the research and development of AI-based ultrasound imaging solutions for analyzing COVID-19 patients, representing the importance that this technology has on the front lines.
The clearance of the LVivo Bladder, however, represents the next step for the company overall. “Extending our focus to abdominal areas is part of the company’s vision of making ultrasound analysis more accessible,” DiA CEO and co-founder Hila Goldman-Aslan told The Jerusalem Post. “We started with the cardiac area because it’s the most difficult to analyze. Once we saw we were analyzing the main issues within the cardiac area – and with this right ventricle analysis, we’re completing the package – we knew we could start extending our focus to other parts of the body, as well.”
Focusing on the bladder is very important. Studies have shown that healthcare-associated urinary tract infections (UTIs) account for up to 40% of infections in hospitals and 23% of infections in the intensive care unit (ICU). The LVivo Bladder seeks to prevent this by allowing easy ultrasound scans to prevent any unnecessary procedures or catheterization, which lessens the risk of further infections.
The addition of two new FDA clearances to DiA’s LVivo toolbox is reflective of changes in the MedTech industry, which has seen ultrasound imaging and AI-based analysis solutions become more valued by healthcare professionals.
Use of ultrasound is becoming more widespread as an inexpensive alternative compared to MRI and CT scans, so there is considerable interest in making it more accessible as an image modality, Goldman-Aslan explained. Unlike some other companies, however, DiA’s target users are not radiologists, but rather clinicians in the ER, ICU and other point of care settings, where the use of ultrasound is rapidly growing.
However, one of the biggest issues regarding the use of ultrasound, aside from portability, is data analysis. Currently, most medical staff analyze ultrasound data through subjective visual estimation, which has the risk of being biased, as well as being time consuming. Family physicians and paramedics “may not have as much experience or familiarity using ultrasound as, say, an echocardiologist. On top of all that, ultrasound images can be ‘noisy.’ That’s where the AI comes in.
AI is another addition to a physician’s toolbox that helps them make sense of the data,” Goldman-Aslan told the Post. “We’re providing automated and objective analyses that could help users understand the image. Eventually, they can connect the dots and make a decision. That’s the gap we’re closing – to help everyone use the technology easily.”