The United States Food and Drug Administration (USFDA) has granted breakthrough device designation to Qure.ai’s AI-powered Tuberculosis (TB) solution, qSpot-TB, a company statement informed.
The qSpot-TB Artificial Intelligence (AI) is a second read computer-aided detection and diagnosis device that analyses chest X-rays to localise all noted radiological signs suggestive of TB and provide an accompanying conclusion regarding the presence or absence of TB.
Bunty Kundnani, Chief Regulatory Affairs Officer, Qure.ai, stated in the statement, “Qure is committed to pushing the boundaries of AI medical innovation and follows rigorous legislative and regulatory processes in over 85 countries to ensure the highest standards of safety and efficacy of solutions. Achieving the FDA and EU MDR clearances across multiple imaging modalities and global disease areas means that we can support radiology workforces to prioritise patient cases quickly or expedite decision making.”
