Qure.ai’s AI-Powered TB Solution Receives ‘Breakthrough Device’ Status from FDA

This latest regulatory recognition for Qure.ai joins four FDA clearances and 61 EU Medical Device Regulation CE mark approvals over the last 18 months.

Mumbai-based healthtech startup, Qure.ai has received a ‘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.

The AI-powered qSpot-TB is a second-read computer-aided detection and diagnosis device that analyses chest X-Rays to localise all noted radiological signs suggestive of TB. Further, based on these findings, the device generates a report indicating the presence or absence of TB.

This latest regulatory recognition for Qure.ai joins four FDA clearances and 61 European Union Medical Device Regulation (EU MDR) CE mark approvals over the last 18 months.

On the accomplishment, Bunty Kundnani, chief regulatory affairs officer, Qure.ai, 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 we can confidently support radiology workforces to prioritise patient cases quickly or expedite decision-making.”

Growing TB Threats In Western Countries

Following the COVID-19 pandemic, the rates of TB in Western countries including the UK and the USA have ticked upwards. Thereby magnifying the need for continued focus on detection and screening.

After experiencing a continual decline for almost thirty years in the US, TB cases saw an increase by 2021-22. Although still less prevalent than before the COVID-19 pandemic, the Centers for Disease Control and Prevention recorded 8,300 TB cases in 2022.

Similarly, in England, data from the UK Health Security Agency showed cases of TB increased by 7% in the first half of 2023 compared to the same timeframe in 2022.

Additionally, Qure.ai's AI-powered device is expected to offer support to clinical professionals in identifying and diagnosing TB cases promptly.

The ‘Breakthrough Device’ status by FDA represents a significant advancement in AI-assisted tuberculosis diagnosis.

The Breakthrough Devices Program is a voluntary initiative by the US FDA. It is designed for certain medical devices and device-led combination products that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

Quere.ai’s Recent Tech Advancements

In a similar vein, last month, the healthtech startup got clearance for its AI-enabled medical imaging solution- qXR-LN. Marking it the 13th FDA clearance for their AI-enabled medical imaging solutions.qXR – LN. It is a computer-aided detection software designed to identify and highlight regions that indicate suspected pulmonary nodules ranging from 6 to 30 mm in size.

Previously, it also received FDA clearance for qXR-CTR, an AI-enabled chest X-ray solution. The qXR-CTR employs a deep-learning-based computer vision algorithm, designed for physicians across inpatient and outpatient settings, to automate the assessment of cardiothoracic ratio (CTR) on chest radiographs (CXR). It accurately measures the heart's maximum transverse diameter ratio to the thoracic cavity's maximum inner transverse diameter, indicating cardiomegaly on plain film.

Established in 2016 by CEO Prashant Warier, Qure.ai is a global player in medical AI. Headquartered in India, it operates in over 70 countries with offices in London and New York. Their certified medical imaging AI solutions cover a range of medical applications, from analysing neurocritical trauma or stroke CTs to detecting musculoskeletal X-Ray fractures and identifying lung cancer, tuberculosis, and heart failure through chest X-Rays and CT scans.