Therapy Areas: Respiratory
Bayer receives US FDA breakthrough device designation for CTEPH Artificial Intelligence (AI) Pattern Recognition Software
11 December 2018 -

Life science company Bayer revealed on Monday the receipt of the US Food and Drug Administration (FDA) breakthrough device designation for the Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Artificial Intelligence (AI) Pattern Recognition Software in joint development with Merck.

CTEPH is a progressive type of pulmonary hypertension where the thromboembolic occlusion (organized blood clots) of pulmonary vessels gradually builds up and subsequently leads to an increased blood pressure in the pulmonary arteries, resulting in an overload of the right heart.

The company added that the 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 its important they accurately detect CTEPH indicators on CTPA scans and images.

According to the company, the 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.

In conjunction, the CTEPH Pattern Recognition AI 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.

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