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.