FDA grants software for CTEPH breakthrough device designation

The Food and Drug Administration (FDA) has granted Breakthrough Device Designation to artificial intelligence software for chronic thromboembolic pulmonary hypertension (CTEPH) pattern recognition.

The software is currently being developed by Bayer, jointly with MSD. Development of the software will rely on using deep learning methodology to support radiologists by identifying signs of CTEPH in CTPA scans. The software processes image findings of cardiovascular, lung perfusion and pulmonary vessel analyses in combination with the patient’s history of pulmonary embolism. If the development is successful, the software could be deployed via Bayer’s Radimetrics, an informatics technology platform that connects contrast medium with injector and scan information to provide important insights.

Professor Olaf Weber, head of radiology research & development of Bayer’s pharmaceuticals division said: “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. 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.”