FDA approves IMIDEX’s AI-powered device VisiRad XR

Betsy Goodfellow | August 18, 2023 | News story | Research and Development FDA, Radiology, pharma, radiology 

The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-powered medical device, VisiRad XR.

The newly-developed software analyses chest X-rays and recognises lung nodules and masses. VisiRad XR intends to improve accuracy when detecting lung nodules in patients while avoiding unnecessary testing orders. The software ensures that the radiologists can easily view the results by sending images with AI-detected lesions with their usual viewing setup.

IMIDEX carried out one standalone performance study and one multi-care clinical validation study on the new device, which it included in its submission to the FDA. The study used over 11,000 patient images and VisiRad XR displayed an 83% sensitivity rate in the identification of lung nodules and masses; this was obtained while maintaining consistent false positives and a fixed device operating threshold.

The chief medical officer at IMIDEX, 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.”

Rebecca Lee

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