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Qure.ai AI-Based Devices Receive CE Mark

March 1, 2023

Qure.ai has received CE mark certification for its artificial intelligence (AI) software for multiple modalities of medical imaging.

The company’s AI technology, which is certified as a Class IIb medical device,  detects abnormalities from chest x-rays, chest computed tomography, head computed tomography and musculoskeletal x-rays.

The EU’s Class IIb designation is generally assigned to devices considered medium to high risk, such as ventilators and intensive care monitoring equipment.

Qure.ai products are in use at more than 1,000 sites globally and validated in 75 countries, the company said.

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