Qure.ai Receives FDA Clearance for AI-Powered Tuberculosis Solution

Qure.ai, a medical imaging AI innovator, has received the Center for Devices and Radiological Health (CDRH) device designation by the FDA for its qSpot-TB AI-powered Tuberculosis (TB) solution. 
 
This is Qure.ai’s fourth FDA clearance. The company also has 61 European Union Medical Device Regulation (EU MDR) CE mark approvals. 
 
qSpot-TB AI is a second-read computer-aided detection and diagnostic device to analyze Chest X-rays and localize all noted radiological signs suggestive of TB. The system provides a conclusion for the presence or absence of TB. 
 
Chief regulatory affairs officer, Bundy Kundani said, “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 prioritize patient cases quickly or expedite decision-making.”
 
Despite experiencing a continual decline for almost 30 years in the US, TB cases saw an increase in 2021 and 2022. The Centers for Disease Control and Prevention recorded 8,300 TB cases in 2022, and in England, the UK Health Security Agency showed a 7% increase in TB in the first half of 2023 when compared to the first half of 2022. 
 
“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 UK and USA have ticked upwards following the Covid-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,” Kundani concluded.