FDA OKs IMIDEX's AI-powered device to spot lung nodules

IMIDEX, a company specialising in the advancement of artificial intelligence AI-driven solutions for lung cancer, has secured clearance from the U.S. Food and Drug Administration (FDA) for its flagship software, VisiRad XR, empowered by AI. This software is designed to scrutinise chest X-rays, highlighting potential lung nodules and masses for further examination.

Harnessing machine learning techniques and developed with meticulously curated global training data, the software offers clinicians an enhanced view of lung abnormalities that might often be overlooked. This capability assists in the identification of potential future lung cancer cases in both outpatient and emergency care settings.

Dr. Raj Chopra, IMIDEX's Chief Medical Officer, emphasised the importance of solutions that can enhance radiologist performance and mitigate burnout: "Radiologists are seeking tools to enhance their capabilities and alleviate burnout. As workloads increase and staff decreases, utilities like VisiRad XR prove advantageous not only for patient well-being but also for sustaining radiologists' optimal practice."

The plug-and-play nature of the VisiRad XR tool seamlessly integrates into existing radiology workflows, channelling images containing AI-detected anomalies back to radiologists within their familiar viewing environments. Results are displayed directly alongside the image for immediate interpretation. VisiRad XR aims to bolster the detection rate of lung nodules and masses during routine care, effectively providing a "second opinion" in the realm of chest X-rays.

In a retrospective study encompassing images from 11,000 patients, VisiRad XR demonstrated an 83% sensitivity in spotting lung nodules and masses, accompanied by a fixed false positive per image rate and operating threshold. IMIDEX indicated that the application could potentially aid hospitals in identifying up to an additional 750 lung nodules per year.

Richard Vlasimsky, IMIDEX's CEO, highlighted the significance of this achievement: "Securing this clearance empowers us to offer radiologists a tool with tangible benefits, ensuring more patients receive the necessary care. Considering that chest X-rays are the most common radiologic procedure worldwide, VisiRad XR holds immense potential for impact. We're excited to take the next stride in our mission to save lives lost to lung cancer."

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