Breakthrough status for CTEPH deviceFebruary 4, 2019
The US FDA granted breakthrough device designation to the artificial intelligence software for chronic thromboembolic pulmonary hypertension (CTEPH) pattern recognition, which Bayer is currently developing 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 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.
A rare form of pulmonary hypertension, CTEPH affects an estimated 8 to 40 people per million globally. CTEPH can be difficult to diagnose because its symptoms are similar to those of other lung diseases.