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Qure.ai's qSpot-TB Receives FDA Breakthrough Device Designation

Qure.ai, a pioneer in medical imaging AI, has achieved a significant milestone with its AI-powered Tuberculosis (TB) solution, qSpot-TB, receiving breakthrough device designation from the FDA's Center for Devices and Radiological Health (CDRH).

This prestigious recognition adds to Qure.ai's impressive track record, which includes four FDA clearances and 61 CE mark approvals under the European Union Medical Device Regulation (EU MDR) in the past eighteen months.

qSpot-TB utilizes artificial intelligence as a second-read computer-aided detection and diagnosis tool, analyzing chest X-rays to pinpoint radiological signs indicative of TB. It provides conclusive assessments regarding the presence or absence of TB, aiding clinical professionals, particularly amidst a recent surge in TB cases across developed nations like the United States.

Bunty Kundnani, Qure.ai's Chief Regulatory Affairs Officer, emphasizes the company's commitment to advancing AI medical innovation while adhering to rigorous regulatory processes across over 85 countries. The FDA and EU MDR clearances across various imaging modalities and disease areas reflect Qure.ai's dedication to ensuring safety and efficacy in its solutions, facilitating prompt patient prioritization and decision-making in radiology practice.

The FDA's recognition of qSpot-TB as a breakthrough device underscores its potential in revolutionizing TB diagnosis with AI assistance. With TB cases on the rise even in Western societies post-Covid-19, the need for enhanced detection and screening tools becomes paramount. Qure.ai looks forward to collaborating closely with the FDA throughout the breakthrough device regulatory process.

Professor Kenneth G. Castro from Emory University highlights the importance of global collaboration and innovative technology in combating TB, stressing the necessity of sustained efforts until the disease is eradicated. Despite a decades-long decline in TB cases in the United States, there has been a recent uptick, with the CDC reporting 8,300 cases in 2022. Similarly, England has witnessed a 7% increase in TB cases in the first half of 2023 compared to the same period in 2022, according to data from the UK Health Security Agency.

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