IMIDEX Announces FDA 510(k) Clearance For Visirad XR, An AI-powered Medical Device

IMIDEX, a leader in developing AI-based solutions to address lung cancer, announces that it has received FDA 510(k) clearance for its flagship VisiRad XR product. VisiRad XR is an AI-powered software that analyzes chest X-rays and highlights possible lung nodules and masses. Employing state-of-the-art machine learning techniques, the software was developed using curated training data from across the world. VisiRad XR gives clinicians a closer look at often-overlooked lung lesions, potentially enabling identification of future lung cancers in outpatient and emergency department settings.

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“Radiologists are looking for solutions to help elevate their performance and reduce burnout,” said Dr. Raj Chopra, Chief Medical Officer of IMIDEX. “With volumes increasing and staffing decreasing, tools like VisiRad XR are beneficial not only for patient care, but for helping radiologists continue to practice to their full potential.”

VisiRad XR provides a turnkey solution that plugs in to the current radiology workflow. The software routes images with AI-detected lesions back to radiologists within their native viewing environment, allowing them to see VisiRad XR’s results right behind the primary image for interpretation. Requiring no additional testing orders, VisiRad XR seeks to increase the number of detected lung nodules and masses in patients seen through routine care.

“Currently, only 20% of lung cancers are detected in the early stages and only 4% of patients at high-risk for lung cancer are routinely screened.” said Dr. Paul Bunn, Distinguished Professor of Medical Oncology at University of Colorado and former ASCO president, “Increasing our detection of existing lung nodules is key to identifying it early, when the patient’s likelihood of survival is markedly higher.”

Lung cancer takes over 127,000 lives in the US annually, with half of cases identified in later stages when five-year survival rates are only 5-10%. While CT screening is the best way to identify cancerous lung lesions, patient compliance with screening recommendations is low, and chest X-rays are far more ubiquitous in standard care than guideline-recommended low-dose CT scans. Lung nodules, an early indication of lung cancer, can be detected in chest X-rays; however, they are often overlooked due to their visual subtlety and rarity in routine care. VisiRad XR provides clinicians a “second-read” for lung nodules and masses in chest X-rays.

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IMIDEX conducted two large-scale studies on VisiRad XR that it submitted to the FDA as the heart of its 510(k) submission: a standalone performance study and a multi-center clinical validation study.

In the retrospective standalone study performed by IMIDEX utilizing over 11,000 patient images, VisiRad XR detected lung nodules and masses at a sensitivity of 83% with a fixed false positives per image rate and fixed device operating threshold. For an average hospital in the US performing 50,000 chest X-rays annually, VisiRad XR could identify up to an additional 750 lung nodules or masses in a year.

Clinical evaluation of VisiRad XR was performed through a multi-reader, multi-case clinical validation study using six hundred images and twenty-four radiologists from across the country. VisiRad XR improved each reader’s ability to detect pulmonary nodules and masses within chest X-rays, demonstrated through statistically significant improvement in area under the curve of the receiver operating curve (AUC) and increased sensitivity across all readers, regardless of experience level, specialty, or training background.

“Achieving this clearance enables us to provide a tool to radiologists that can have a tangible benefit in getting more patients the care they need,” said Richard Vlasimsky, CEO of IMIDEX, “Chest X-rays are the most common radiological procedure in the world, which means that the opportunity for VisiRad XR’s impact is enormous. We’re thrilled to take the next step forward in our mission to save lives lost to lung cancer.”

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