Magentiq-Colo device received a 510(k) clearance from the US Food and Drug Administration (FDA) in July 2023. Image Credit: Katy Flaty / Shutterstock.

Israel-based Magentiq Eye has published data from a clinical trial assessing its computer-aided detection colonoscopy tool, Magentiq-Colo CADe.

The results show the software’s superiority in detecting adenomas during colonoscopy.

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The Magentiq-Colo device uses artificial intelligence (AI) to analyse video output from the colonoscope during the procedure in real time. It then highlights the adenoma lesions in the video output to help physicians detect these polyps. The device has a 99.6% polyp-wise sensitivity and 98% specificity. The device received a 510(k) clearance from the US Food and Drug Administration (FDA) in July 2023.

The data from the multicentre trial (NCT04640792) that evaluated 916 patients who were divided into conventional colonoscopy and Magentiq-Colo groups was published in the Lancet Digital Health journal. The global trial achieved its primary endpoint by demonstrating that there was a 7% absolute value and 37% relative increase in adenomas detected per colonoscopy with Magentiq’s AI-aided colonoscopy tool, compared to the conventional colonoscopy group.

The study also had a second primary endpoint of adenoma per extraction (APE), defined as the total number of histologically confirmed adenomas divided by the total number of extractions (polypectomies or biopsies) during the first examination. The mean per patient APE was higher in the Magentiq-Colo group, compared to the conventional colonoscopy group.

The adenoma miss rate was decreased by 17% in absolute value and 47% in relative value within the Magentiq-Colo group, compared to the conventional colonoscopy group. Furthermore, there was an increased detection of small adenomas sized 6mm–9mm with the use of Magentiq-Colo.

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Adenoma detection and removal is an important part of colorectal screening, with higher adenoma detection rates associated with a reduced risk of developing colorectal cancer. Colorectal cancer is the third most common cancer worldwide, as per the World Cancer Research Fund International.

The market for colonoscopes was worth $4.92bn in 2023, and it is expected to grow at a compound annual growth rate (CAGR) of 7% during 2023-2033, as per a 2023 GlobalData report. The use of technology such as AI has been increasing in recent years, especially in disease detection and imaging.

GlobalData is the parent company of Clinical Trials Arena.

In November 2023, NVIDIA partnered with India-based L&T Technology Services Limited (LTTS) to develop software-defined architectures for endoscopy-oriented medical devices.

In October 2023, Philips and Quibim 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.