FDA Grants Breakthrough Device Designation for Bayer and Merck’s AI Software

FDA Grants Breakthrough Device Designation for Bayer and Merck's AI Software
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Recently, Bayer revealed that the U.S. Food and Drug Administration (FDA) won a  breakthrough device designation for its AI software designed for supporting the clinical decision-making of chronic thromboembolic pulmonary hypertension (CTEPH), which is a life-threatening and progressive illness.

Currently, Bayer is working on creating the CTEPH Pattern Recognition AI software in conjunction with MSD, which is the official trade name of the Kenilworth, N.J-based Merck & Co.

Chronic thromboembolic pulmonary hypertension or CTEPH is a rare pulmonary hypertension condition that is said to affect nearly five individuals per million, each year across the globe.

Due to the similarity of the symptoms to other lung illnesses such as COPD and asthma, diagnosing CTEPH can be challenging.

As a rare condition, doctors may not always detect chronic thromboembolic pulmonary hypertension (CTEPH) due to various factors such as a lack of clinical awareness as well as complicated findings relating to the pulmonary vessels, lung, and heart.

Ventilation/perfusion scan (V/Q scan) and computed tomography pulmonary angiography (CTPA) are the most common diagnostic modal qualities for detecting CTEPH.

Radiologists may now have the first chance to detect CTEPH in their patients; hence, it is crucial that they identify CTEPH indicators, particularly on CTPA images.

Bayer and Merck & Co ’s software is designed to support radiologists, who are in most cases on the front row seat of detecting CTEPH patients through evaluating image findings from lung perfusion, cardiovascular and pulmonary vessels together with the clinical history of a patient.

Both pharmaceutical entities claimed that their software could eventually be deployed through Bayer’s Radimetrics™, which is an informatics technology platform that helps in connecting contrast medium with both injector and scan information in a bid to provide crucial insights/

“Bayer is looking forward to leveraging our expertise in Radiology to develop 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 new Food and Drug Administration(FDA) Breakthrough Device Program was developed as a section of the 21st Century Cures Act and is anticipated to accelerate the review and assessment of the software.

The program is aimed at helping patients to have increased timely access to devices and innovative technologies that offer more effective treatment or even diagnosis for irreversibly or life-threatening debilitating illnesses through accelerating their creation, assessment and review.

Nevertheless, Bayer and Merck noted that the creation of their CTEPH Pattern Recognition AI software is still complicated, considering the nature of the technology and illness.

For Bayer, this recent move could be the next major step in the company’s use of artificial intelligence.

The development of CTEPH Pattern Recognition Artificial Intelligence Software followed November’s deal with Genpact intended to integrate artificial intelligence to its pharmacovigilance systems via a multi-year business deal with the firm.

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