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FDA grants special designation for Bayer AI software

Bayer announced in a release that the U.S. Food and Drug Administration granted a breakthrough device designation for an AI pattern recognition software that it is jointly developing with Merck.

The software is designed for the treatment of chronic thromboembolic Pulmonary Hypertension (CTEPH), a rare form of pulmonary hypertension that is often difficult to diagnose because symptoms often mimic those of asthma or chronic obstructive pulmonary disease (COPD).

Working together, Bayer and Merck have…

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