Health-ITNews adds new FDA breakthrough device status to growing list of regulatory milestones 

Four FDA clearances and 61 EU MDR CE tags were achieved for AI in 18 months

Medical imaging AI innovator,, has received breakthrough device designation from The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) for its AI-powered Tuberculosis (TB) solution, qSpot-TB. 

This latest regulatory accolade for joins four FDA clearances and 61 European Union Medical Device Regulation (EU MDR) CE mark approvals over the last eighteen months. 

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. This may support clinical workforces, especially during a recent uptick in TB incidences in developed nations including the US. 

Bunty Kundnani, Chief Regulatory Affairs Officer,, states, “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 FDA and EU MDR clearances across multiple imaging modalities and global disease areas means that we can confidently support radiology workforces to prioritise patient cases quickly or expedite decision-making.” 

“The breakthrough device designation granted to Qure’s qSpot-TB device by the FDA marks a step forward in the field of tuberculosis AI-assisted diagnosis. TB is a highly infectious disease affecting the lungs and is not just the premise of developing nations. Rates of TB in Western societies such as the UK and the US have ticked upward following the pandemic, magnifying the need for continued focus on detection and screening. We look forward to working closely with the FDA on the onward breakthrough device regulatory process,” he adds. 

“The increase in TB cases in the US is a reminder of the importance of collective global efforts to continue the fight against the disease until eliminated. We cannot let our guard down. Innovate technology is a crucial component for accelerated progress to successfully end TB globally”, said Professor Kenneth G Castro, MD, FIDSA, Co-Director, Emory TB Center, Hubert Department of Global Health & Department of Epidemiology, Rollins School of Public Health, Division of Infectious Diseases, Department of Medicine, School of Medicine, Emory University.




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