DeepTek's Chest X-ray AI Achieves EU MDR Certification

DeepTek’s breakthrough Chest X-ray AI now globally certified, boosting diagnostic speed, accuracy, and access to critical healthcare!

Highlights:

DeepTek’s Chest X-ray AI solution is now a certified Class IIb medical device under EU MDR
The AI can detect over 20 lung disorders and recognize medical devices in chest X-rays, including pediatric cases
With CE-marking and US FDA CADe certification, DeepTek can expand its solutions globally, helping areas with high TB burden and radiologist shortages

DeepTek reports that its Chest X-ray AI solution has been certified as a Class IIb medical device under the European Union Medical Device Regulation (EU MDR) ().

Chest X-ray AI Solution Helps Identify 20+ Lung Disorders

The purpose of the Chest X-ray AI solution is to help doctors analyze frontal chest X-rays (AP/PA views). With the help of sophisticated machine learning, the solution can identify more than 20 different lung disorders, including rib and clavicular fractures, as well as nodules, lung masses, TB, and pneumothorax.

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TOP INSIGHT

Did you know?
DeepTek’s AI can spot lung abnormalities and find medical devices like pacemakers- making it a virtual assistant for doctors under pressure! #healthcareai #deeptek #medicalinnovation #chestxray #medindia

Furthermore, the solution recognizes a number of medical devices that are frequently seen in intensive care units and inpatient settings, including pacemakers, chest leads, and different tubes, which offer crucial assistance in challenging clinical situations.

This approach can also read pediatric chest X-rays and detect pediatric tuberculosis and pneumonia, hence improving diagnostic capacities in younger populations, which are frequently underserved by traditional AI models.

DeepTek Acquires CE-Mark and Full US FDA CADe Certification

DeepTek can now make its solution available across Europe and other CE-mark-recognized locations, providing a strong tool to boost productivity, decrease diagnostic delays, and promote quality care delivery on a large scale.

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Furthermore, it has acquired full US FDA CADe certification, demonstrating its dependability and clinical rigour in medical imaging applications.

The need for such solutions is especially urgent in areas with a high tuberculosis burden and limited access to specialist radiologists. With a rising tuberculosis burden and an increasing radiology workload, CE certification paves the path for implementation in Europe, Asia, Africa, and other CE-marked locations where AI-driven diagnostics are not only helpful but critical.

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The technology has been deployed at 325 TB screening sites, supporting national TB programs and public health activities across several geographies.

Reference:

DeepTek's Chest X-ray AI solution receives CE MDR Class IIb certification - (https://www.expresshealthcare.in/news/deepteks-chest-x-ray-ai-solution-receives-ce-mdr-class-iib-certification/448793/)

Source-Medindia

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