The real-world data collection study is designed to assess potential cost-effectiveness, timesaving and a reduction in side effects by utilising the CADScor System to identify non-obstructive CAD in chest pain patients compared to traditional stress imaging tests. Image Credit: Pornpimon Ainkaew / Shutterstock.

US-based Acarix has initiated a real-world study that compares its AI-powered CADScor System’s clinical workflow efficiency with traditional stress tests to see which can identify patients with coronary artery disease (CAD) faster and improve the efficiency of emergency departments and clinics.

Acarix’s CADScor System has received de-novo clearance by the US Food and Drug Administration (FDA) and a European CE-mark.

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The CADScor System is designed as a first-line diagnostic aid that uses acoustics and AI to analyse blood flow to rule out CAD. The system gives out results in under ten minutes and rules out CAD with at least 96% negative predictive value at the point of care.

The real-world data collection study is designed to assess potential cost-effectiveness, timesaving and a reduction in side effects by utilising the CADScor System to identify non-obstructive CAD in chest pain patients compared to traditional stress imaging tests.

The data for 200 patients with chest pain will be collected from the University of California, Davis, from both the emergency department and outpatient cardiology clinic. The enrolment is expected to start in Q2 this year.

Acarix expects the study data to be used to show the economic benefits of its CADScor System and raise awareness of the device.

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GlobalData forecasts AI to be a key driver of medical device innovation. The AI market generated approximately $93bn in sales in 2023, as per GlobalData analysis. Multiple companies such as Roche and Amazon have developed AI algorithms to improve workflows and disease diagnosis.

GlobalData is the parent company of Clinical Trials Arena.

The use of AI in medical imaging and diagnostics received significant investment last year, with multiple companies raising capital to advance the use of AI in imaging diagnostics. In October 2023, US-based Clarix Imaging raised $10m for its US FDA-cleared point-of-care 3D imaging platform. Clarix Imaging’s device enables real-time assessment of specimens in the operating room for lumpectomy procedures.

In November 2023, NVIDIA partnered with India-based L&T Technology Services (LTTS) to develop software-defined architectures for endoscopy-oriented medical devices. As part of the agreement, NVIDIA will supply its Holoscan software and NVIDIA IGX Orin hardware, a popular AI technology used in the medical imaging sector.

In October 2023, Philips and Quilbim partnered to develop AI-based imaging and reporting solutions for MR prostate examinations. The collaboration leveraged Philips’ high-speed MR imaging and Quibim’s QP-Prostate software to streamline diagnosis.