The FDA has granted breakthrough device designation to an artificial intelligence software that is being developed by Bayer and Merck for CTEPH pattern recognition.
Bayer announced that the U.S. Food and Drug Administration (FDA) has granted the Breakthrough Device Designation for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pattern Recognition on December 3rd, 2018. Bayer is currently developing this with MSD (known as Merck in the United States of America and Canada).
In a press release, Bayer explained that this software will have support radiologists identifying CTEPH in computed tomography pulmonary angiography, also known as CTPA, scans.
CTEPH is a rare form of pulmonary hypertension that affects millions around the world. It affects 5 individuals per million per year globally. It is often hard to diagnose since the symptoms are similar to other lung-related diseases. For example, CTEPH’s symptoms are similar to Chronic Obstructive Pulmonary Disease (COPD).
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) is a disease that is associated with pulmonary embolism. This disease is life-threatening, as a blood clot can form in the vein deep in the legs and travel up to the lungs. The pulmonary vessels build up walls which lead to increased blood pressure in the pulmonary arteries. Thus, the right side of the heart is in overload mode.
Computed Tomography Pulmonary Angiography, also known as CTPA, is a medical diagnostic test that uses computed tomography (CT scans) to gather images of the pulmonary arteries. This method has been used for several years now. CTPA scans can determine if blood clots are the reason for the high blood pressure in the lungs. Other common diagnostic modalities to detect CTEPH are ventilation/perfusion scans.
CTPA is a gold-standard method that is used to detect the formation of blood clots and if they are blocking blood vessels in the lungs, resulting in pulmonary hypertension (a characteristic feature of CTEPH). The collaboration of Bayer and MSD will help progress this software by fully evaluating this field of study.
In order to identify signs of CTEPH, the Pattern Recognition AI Software will use various methods to help radiologists identify signs of CTEPH in CTPA scans. This software works by viewing different images and their findings from lung perfusion, cardiac muscle, and pulmonary vessels. The patient’s clinical history is also taken into consideration, including their pulmonary embolism.
If this development is successful, the CTEPH Pattern Recognition AI software can be deployed via Bayer’s Radimetrics™. If this software is successful, radiologists will be able to fully analyze CTPA images in order to recognize the signs of CTEPH.
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Bayer’s Radimetrics™ is a platform that connects contrast scan information into a reliable solution through Seamlessly Smart™ in order to provide insights to the various different radiology teams. It is a web-based platform that increases efficiency and helps to reduce error. This platform merges a patient’s dose with his/her histories across the enterprise sites to bring analysis and quality solutions to the point of care.
Bayer’s Radimetrics™ empowers workflow by combining both radiation exposure and contrast into one system. It also provides insights for improvement across the enterprise.
The status given by the FDA to this new software will enhance the tool’s development and enable more effective diagnoses for CTEPH patients. It will also pave the way to develop further technology to help treat CTEPH patients.
This FDA approved device will help patients have more timely access to the breakthrough technology for more effective and efficient ways of diagnosing lung-related diseases. The development of the Breakthrough Device Designation remains complex, considering how complicated the disease is in relation to the technology.
“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. He continues to say, “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.’
This is a major step for Bayer, the global enterprise company that has been working on new ways to incorporate artificial intelligence in the medical field. The development of CTEPH Pattern Recognition Artificial Intelligence Software is intended to use the artificial intelligence technology in its pharmacovigilance systems.