DiA Imaging Analysis, an Israeli provider of AI-based software for ultrasound analysis, has received the US Food and Drug Administration (FDA) approval for LVivo IQS.

LVivo IQS is a new AI-based vendor-neutral software solution that enables the acquisition of high-quality interpretable cardiac ultrasound images that support better clinical assessments of the heart.

According to the company, high-quality cardiac ultrasound image acquisition can be challenging due to the constant motion of the heart and its deep location in the chest.

Its new LVivo IQS offers Image Quality Score, which delivers real-time image quality feedback while scanning the left ventricle of the heart to assess its performance, said the company.

DiA Imaging Analysis CEO and founder Hila Goldman-Aslan said: “LVivo IQS is the first of DiA’s 9 FDA-approved software solutions that empowers healthcare professionals with real-time feedback to enable the capture of high-quality ultrasound images.

“By harnessing the power of AI, our full suite of software solutions helps ultrasound users overcome two major challenges in the field – scanning high-quality images and accurately analysing them.

“This holistic approach aligns with our mission of leveraging AI to make ultrasound image capture and analysis processes smarter and more accessible.”

LVivo IQS uses colours and numerical scoring to indicate the quality of the image, helping users to produce optimal images for more accurate and reproducible analysis of the heart.

The US FDA approval was based on a clinical study that evaluated the safety and efficacy of the AI-backed ultrasound software.

The study results showed high agreement between LVivo IQS AI’s quality score feedback and the ability to obtain clinically interpretable images.

In the trial, 91% of images saved by point-of-care residents using LVivo IQS were found to be clinically interpretable images by the Cardiologist.

LVivo IQS study principal investigator Lior Fuchs said: “For precise heart diagnosis and treatment, high-quality cardiac ultrasound imaging is necessary in both point-of-care and other settings.

“LVivo IQS AI software will assist us in obtaining faster and clearer images to aid our real-time clinical decision-making process.”

In March last year, DiA signed a multi-year agreement with Change Healthcare to expand its AI solutions for Echo-lab cardiac exams.