Bayer and Merck AI Software Granted FDA Breakthrough Device Designation Status

The new FDA Breakthrough Device Program was developed as a section of the 21st Century Cares Act and is anticipated to accelerate the review and assessment of software writes KC Cheung writing with Algorithmxlab. Bayer recently revealed that its AI software designed for supporting the clinical decision making process of chronic thromboembolic pulmonary hypertension (CTEPH) was awarded breakthrough device designation status. Bayer is co-developing the CTEPH Pattern Recognition AI software in conjuncture with Merck. CTEPH is a rare pulmonary hypertension condition that is said to impact nearly five individuals per million, each year worldwide.