The Chest X-ray AI solution is designed to assist physicians in interpreting frontal chest X-rays
DeepTek, a provider of AI-powered radiology solutions, is proud to announce 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 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, 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 recognised 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.
