FDA grants breakthrough status to joint Merck-Bayer AI program

Merck and Bayer have been granted FDA Breakthrough Device Designation for the collaborative Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Artificial Intelligence Pattern Recognition software. CTEPH can be difficult to diagnose because its symptoms are similar to asthma and chronic obstructive pulmonary disease symptoms. CTEPH affects five people per million annually worldwide. Computed tomography pulmonary angiography and a ventilation/perfusion scan can be used to determine if thromboembolic occlusion is causing pulmonary hypertension in patients. Get the full story on our sister site, Medical Design & Outsourcing. The post FDA grants breakthrough status to joint Merck-Bayer AI program appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Bayer Merck Source Type: news