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Qure.ai Secures FDA Breakthrough Device Status, Strengthening Regulatory Momentum

Qure.ai has recently achieved a breakthrough device designation from the FDA's Center for Devices and Radiological Health (CDRH) for its innovative AI-powered Tuberculosis (TB) solution known as qSpot-TB. This groundbreaking designation highlights a significant stride in medical imaging technology, particularly in addressing the resurgence of TB cases in developed nation’s post-COVID-19.

qSpot-TB functions as a second-read computer-aided detection and diagnosis device, specializing in analyzing Chest X-rays for signs indicative of TB. It offers a conclusive assessment regarding the presence or absence of TB, thereby potentially revolutionizing TB diagnosis and management.

The rise in TB cases in developed countries such as the United States and the United Kingdom underscores the pressing need for advanced diagnostic tools and screening methods. The qSpot-TB device's capability to identify radiological signs suggestive of TB could greatly enhance clinical workflows and improve diagnostic accuracy.

By collaborating closely with the FDA on the breakthrough device regulatory process, Qure.ai aims to expedite the deployment of qSpot-TB, thereby contributing to early detection, intervention, and ultimately, improved patient outcomes in the fight against TB globally.

Source: https://www.globenewswire.com/en/news-release/2024/02/05/2823553/0/en/Qure-ai-adds-new-FDA-breakthrough-device-status-to-growing-list-of-regulatory-milestones.html

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