FDA grants breakthrough device designation to Bayer, Merck AI software

The FDA is speeding up the review process for new software that uses AI to help radiologists diagnose chronic thromboembolic pulmonary hypertension (CTEPH), pharmaceutical company Bayer announced Dec. 3.

CTEPH is described as high blood pressure in the lung arteries and is caused by blood clots. Its symptoms are similar to those of other lung diseases, which makes it difficult to diagnose. The CTEPH Pattern Recognition software—being jointly developed by Bayer and Merck—will use deep-learning methodology to help radiologists identify signs of CTEPH in computed tomography pulmonary angiography (CTPA) scans.  

The FDA’s Expedited Access Pathway Program is designed to help patients receive timely access to devices and breakthrough technologies that “provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives,” according to its website.

The designation means the agency is expected speed up the software’s assessment and review process.

“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 & Development of Bayer AG’s Pharmaceuticals Division, said in a prepared statement. “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.”

Just last month, the agency also granted 510(k) clearance to software that uses AI to detect the presence of brain bleeds in CT images. 

Like much of the healthcare industry, the FDA has also noticed the surge in AI-related medical devices in the market. The agency is developing several initiatives to ensure the safety and efficacy of the devices.