Merck and Bayer have been granted FDA Breakthrough Device Designation for their 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.

The CTEPH Pattern Recognition AI Software will use deep learning to help radiologists identify signs of CTEPH in CTPA scans. The software is able to analyze images from cardiac, lung perfusion and pulmonary vessels along with using the patient’s clinical history. If Bayer and Merck successfully build the software, the two companies suggest that it will be deployed through Bayer’s Radimetrics software, which is an informatics technology platform that connects contrast medium, injector and scan information.

“Bayer is looking forward to leveraging our expertise in radiology to develop a software to support radiologists and treating physicians in the complex diagnostic decision making process of this rare disease,” said Dr. Olaf Weber, head of radiology research and development of Bayer’s pharmaceuticals division, in a press release. “We hope that greater awareness of CTEPH in conjunction with a decision-support tool will eventually assist in diagnosing patients earlier and more reliably, thereby allowing earlier treatment.”

The FDA Breakthrough Device Program is designed to help patients have access to devices and breakthrough technologies in a more timely manner to provide more effective treatment or diagnostics for life-threatening or irreversibly debilitating diseases.