CTEPH Software Receives FDA’s Breakthrough Device Designation

Alice Melão, MSc avatar

by Alice Melão, MSc |

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The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to  software being developed by Bayer and Merck — known as MSD outside the U.S. and Canada — to help identify chronic thromboembolic pulmonary hypertension (CTEPH).

CTEPH is a rare form of pulmonary hypertension thought to affect approximately five individuals for every million worldwide each year. It can be difficult to diagnose as it manifests with symptoms similar to those of more common pulmonary illnesses such as asthma or chronic obstructive pulmonary disease (COPD).

The CTEPH Artificial Intelligence Pattern Recognition Software uses deep learning protocols to improve the analysis of computed tomography pulmonary angiography (CTPA) scans. This software is being developed to analyze image findings from cardiac, gas exchange, and pulmonary vessels in combination with the patient’s clinical history.

CTPA is a gold-standard methodology used to detect whether a blood clot is blocking vessels in the lungs and causing pulmonary hypertension, the characteristic clinical feature of CTEPH.

If development of the software is successful, it is anticipated that it will help radiologists analyze CTPA images and make it easier to recognize CTEPH signs.

This new regulatory status given by the FDA is expected to expedite the tool’s development and approval to enable more effective and timely diagnosis and treatment of CTEPH patients.

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“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,” Olaf Weber, PhD, head of radiology research and development of Bayer AG’s Pharmaceuticals Division, said in a press release. “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.”

If the CTEPH Artificial Intelligence Pattern Recognition Software is approved, it will be made available to the medical community via Bayer’s Radimetrics software — an informatics technology platform that combines contrast medium, injector, and scan information to provide insights on a patient’s status.Bayer Radimetrics improves the accuracy, accessibility, and consistency of radiology data, and helps deliver more personalized care.

A Conversation With Rare Disease Advocates