FDA providing expedited review of new AI software for diagnosing CTEPH

New software that uses artificial intelligence (AI) to diagnose chronic thromboembolic pulmonary hypertension (CTEPH) will receive an expedited review from the FDA as part of the agency’s breakthrough devices program. The program, first established in 2017 as part of the 21st Century Cures Act, is designed to speed up the development of devices and ensure timely patient access.

The CTEPH Pattern Recognition AI Software analyzes CT pulmonary angiography exams to look for signs of CTEPH. It is being developed by Bayer and Merck.

“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,” Dr. Olaf Weber, head of radiology research & development of Bayer AG's pharmaceuticals division, said in a prepared statement. “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.”