IMIDEX has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-powered medical device, VisiRad XR.

The new software has been developed for analysing chest X-rays and identifying potential lung nodules and masses.

Leveraging advanced machine learning methods, the software was created using curated training data gathered globally.

It enables clinicians to closely examine frequently neglected lung abnormalities. This could potentially help detect upcoming lung cancers in both outpatient and emergency department settings.

The software sends images with AI-detected lesions back to radiologists within their usual viewing setup, therefore enabling them to easily view the results from VisiRad XR alongside the main image for interpretation.

VisiRad XR aims to enhance the detection of lung nodules and masses in patients during routine care without necessitating any extra testing orders.

The company carried out a standalone performance study and a multi-centre clinical validation study on VisiRad XR, which it included in its 510(k) submission to the FDA.

IMIDEX’s retrospective study used a dataset of more than 11,000 patient images. In this study, VisiRad XR exhibited an 83% sensitivity in identifying lung nodules and masses.

It was achieved while maintaining a consistent rate of false positives per image and a fixed device operating threshold.

IMIDEX chief medical officer Dr Raj Chopra said: “Radiologists are looking for solutions to help elevate their performance and reduce burnout.

“With volumes increasing and staffing decreasing, tools like VisiRad XR are beneficial not only for patient care but for helping radiologists continue to practise to their full potential.”