DeepTek’s chest X-ray AI solution receives CE MDR Class IIb certification
New Delhi: DeepTek, a leading provider of AI-powered radiology solutions, has announced that its Chest X-ray AI solution has received CE certification under the European Union Medical Device Regulation (EU MDR) as a Class IIb medical device.
This marks a significant milestone in DeepTek’s commitment to delivering safe, effective, and scalable AI tools to transform diagnostic radiology worldwide.
The Chest X-ray AI solution is designed to assist physicians in interpreting frontal chest X-rays (AP/PA views). Powered by advanced machine learning, the solution detects a host of lung conditions such as nodules, lung masses, tuberculosis, pneumothorax, and over 20 other findings, including rib and clavicular fractures. In addition, the solution identifies multiple medical devices commonly encountered in inpatient and ICU settings, such as chest leads, pacemakers, and various tubes, providing critical support in complex clinical scenarios.
A unique feature of this solution is its ability to interpret pediatric chest X-rays, including the detection of pediatric tuberculosis and pneumonia, enhancing diagnostic capabilities in younger populations—a segment often underserved by conventional AI models.
“This CE MDR Class IIb certification reflects our deep commitment to clinical excellence and patient safety, ”said Dr Amit Kharat, Co-Founder of DeepTek.
“Our Chest X-ray AI solution acts as a concurrent reading aid, highlighting regions of suspicion to improve radiologist efficiency and diagnostic confidence.”
The certification enables DeepTek to expand the availability of its solution across Europe and other CE-mark recognized regions, offering a powerful tool to enhance productivity, reduce diagnostic delays, and support quality care delivery at scale. With this regulatory clearance for TB and other critical lung conditions, DeepTek’s AI-powered Chest X-ray solution is a trusted and clinically validated tool used across public health screening and hospital workflows. Additionally, it is among the few solutions to have received comprehensive US FDA CADe approval, further reinforcing its reliability and clinical rigor in medical imaging applications.
The need for such solutions is particularly urgent in regions grappling with a high TB burden and limited access to expert radiology. With a staggering TB burden and growing radiology workload, CE certification paves the way for deployment across Europe, Asia, Africa, and other CE-mark-recognized regions whereAI-driven diagnostics are not just valuable—but vital. This milestone is not just about regulatory success—it’s about saving lives through early detection and bridging gaps in healthcare access.
DeepTek’s Chest X-ray AI solution is already making a meaningful impact, having screened over 2 million people for TB. The solution is deployed across 325 sites for TB screening, supporting national TB programs and public health initiatives across multiple geographies.
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