Qure.ai, a leader in medical imaging AI, achieves FDA breakthrough device status for its qSpot-TB solution, enhancing its regulatory standing alongside four FDA clearances and 61 EU MDR CE marks within 18 months. qSpot-TB, a second-read AI system, aids in TB diagnosis by analyzing Chest X-rays, crucial amidst rising TB incidences post-COVID-19 in developed nations. Regulatory milestones extend beyond TB, encompassing FDA approvals for various imaging modalities. Bunty Kundnani, Qure.ai’s Chief Regulatory Affairs Officer, emphasizes the company’s global adherence to safety and efficacy standards, underlining its role in supporting healthcare professionals worldwide. Professor Kenneth G. Castro highlights the pivotal role of technology in the fight against TB. The increase in TB cases in the US and England underscores the urgency for innovative solutions, positioning Qure.ai at the forefront of AI-driven medical diagnostics.
Qure.ai, a trailblazer in medical imaging AI, attains FDA breakthrough device designation for its qSpot-TB solution, marking a significant milestone in its regulatory journey. Alongside this achievement, Qure.ai boasts four FDA clearances and 61 EU MDR CE marks within a remarkably short span of 18 months. qSpot-TB offers a sophisticated AI-powered approach to TB diagnosis, catering to the pressing need for enhanced detection amidst a resurgence of TB cases, particularly in developed nations post-COVID-19. This regulatory accolade aligns with Qure.ai’s overarching commitment to advancing AI-driven medical innovations while upholding rigorous safety and efficacy standards across diverse global healthcare landscapes.
Qure.ai’s Breakthrough Device Status & Regulatory Success
The qSpot-TB AI system serves as a second-read computer-aided detection and diagnosis tool, specifically designed to analyze Chest X-rays for signs indicative of TB. By accurately localizing radiological abnormalities associated with TB and delivering conclusive assessments of TB presence or absence, qSpot-TB aims to support healthcare providers, particularly amidst a recent surge in TB cases across developed nations like the United States.
Bunty Kundnani, Chief Regulatory Affairs Officer at Qure.ai, underscores the company’s unwavering commitment to advancing AI-driven medical innovations while adhering to stringent regulatory standards across more than 85 countries. Kundnani emphasizes that obtaining FDA and EU MDR clearances across various imaging modalities and disease areas empowers Qure.ai to assist radiology professionals in efficiently prioritizing patient cases and expediting diagnostic decisions.
“The FDA’s breakthrough device designation for qSpot-TB marks a significant milestone in the realm of AI-assisted TB diagnosis,” Kundnani remarks. He further highlights the increasing prevalence of TB in Western societies post-COVID-19 and underscores the urgent need for enhanced detection and screening measures. Kundnani expresses eagerness to collaborate closely with the FDA throughout the subsequent breakthrough device regulatory process, underscoring Qure.ai’s commitment to combatting TB on a global scale.
Professor Kenneth G. Castro, MD, FIDSA, Co-Director of the Emory TB Center, stresses the critical role of innovative technologies in accelerating efforts to eradicate TB worldwide. He emphasizes the importance of sustained global collaboration and technological innovation in combating TB effectively.
In the United States, TB cases, after experiencing a steady decline for nearly three decades, saw an uptick in 2021/22. Although still lower than pre-pandemic levels, the Centers for Disease Control and Prevention reported 8,300 tuberculosis cases in 2022. Similarly, in England, data from the UK Health Security Agency revealed a 7% increase in TB cases during the first half of 2023 compared to the corresponding period in 2022.
Qure.ai has achieved several other notable regulatory milestones, including FDA clearance for qXR-LN, designed to detect and localize lung nodules; qXR-CRT, for measuring cardiothoracic ratio (CTR) values; qXR-PTX-PE, for triaging pneumothorax (PTX) and pleural effusion (PE) in emergency settings; and qER, tailored for head CT scans.
Qure.ai’s attainment of FDA breakthrough device status for qSpot-TB signifies a pivotal moment in the landscape of AI-assisted medical diagnostics. This achievement, alongside numerous other regulatory milestones, underscores Qure.ai’s unwavering dedication to revolutionizing healthcare through innovative AI solutions. As TB cases witness a resurgence in countries like the US and England post-COVID-19, the need for advanced diagnostic tools becomes increasingly urgent. Through its cutting-edge technologies and global regulatory compliance efforts, Qure.ai stands poised to make substantial contributions to combating TB and addressing other critical healthcare challenges worldwide. Collaborative efforts between industry leaders, regulatory bodies, and healthcare professionals will be essential in realizing the full potential of AI in revolutionizing patient care and diagnostic accuracy.
