FDA grants breakthrough device designation to Bayer, Merck’s AI for spotting CTEPH

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Bayer and Merck hope the program will create a larger market for its Adempas tablet, which is approved for CTEPH and pulmonary arterial hypertension. While Bayer developed the drug, Merck holds the rights to Adempas outside the U.S. (Wikimedia Commons)

The FDA granted Bayer and Merck & Co. a breakthrough device designation for an artificial intelligence-based pattern recognition software used to spot a rare form of pulmonary hypertension in CT scans.

Chronic thromboembolic pulmonary hypertension (CTEPH)—a progressive disease estimated to affect five out of every million people globally—can be difficult to diagnose, with respiratory symptoms similar to those of asthma or chronic obstructive pulmonary disease.

Computed tomography pulmonary angiography, or CTPA, as well as ventilation-perfusion scans, can determine whether blood clots are causing high blood pressure in the lungs and the right side of the heart.


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Bayer and Merck hope the program will create a larger market for its Adempas (riociguat) tablet, which was approved in 2013 for inoperable or persistent CTEPH, as well as pulmonary arterial hypertension, as a way to improve exercise capacity. Merck previously acquired the rights to Adempas outside the U.S., where the company is known as MSD.

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The deep learning software aims to support radiologists by identifying signs of CTEPH in CTPA scans, analyzing images of cardiac, lung perfusion and pulmonary vessels, as well as the patient's clinical history.

“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," said Olaf Weber, Ph.D., head of radiology R&D in Bayer's pharmaceuticals division, in a release.

Bayer hopes to deploy the final product through its Radimetrics software platform, which integrates contrast medium, injector and scan data from multiple imaging modalities.

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