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FDA grants breakthrough device designation for CTEPH pattern recognition AI software from Bayer and Merck

Press releases may be edited for formatting or style
WHIPPANY, N.J. and PITTSBURGH, Dec. 3, 2018 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Artificial Intelligence (AI) Pattern Recognition Software, which Bayer is currently developing jointly with Merck, known as MSD outside the U.S. and Canada.

A rare form of pulmonary hypertension, CTEPH affects an estimated 5 individuals per million per year globally.i CTEPH can be difficult to diagnose because its symptoms are similar to those of other conditions such as asthma or Chronic Obstructive Pulmonary Disease (COPD). i,ii Being a rare disease, physicians may not always recognize CTEPH. Computed Tomography Pulmonary Angiography (CTPA) as well as a ventilation/perfusion scan (V/Q scan) are used to determine if thromboembolic occlusion is causing the pulmonary hypertension. Radiologists may have the first opportunity to identify CTEPH in a patient; therefore it's important they accurately detect CTEPH indicators on CTPA scans and images.

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Development of the CTEPH Pattern Recognition AI Software will use deep learning methodology to support radiologists by identifying signs of CTEPH in CTPA scans. This software analyzes image findings from cardiac, lung perfusion and pulmonary vessels in combination with the patient's clinical history. If the development is successful, the software could be deployed via Bayer's Radimetrics software, an informatics technology platform that connects contrast medium, injector and scan information to provide important insights.

"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," said Prof. Dr. Olaf Weber, Head of Radiology Research & Development of Bayer AG's Pharmaceuticals Division. "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."

The FDA Breakthrough Device Program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases by expediting their development, assessment, and review. While the FDA Breakthrough Device Designation is expected to expedite the software's assessment and review, its development remains complex given the nature of the disease and technology.
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