The FDA has granted breakthrough device status to the generative AI model Cognita CXR. This is the first generative model in radiology to receive such a designation.
The model was developed by Cognita, the artificial intelligence division of Mosaic Clinical Technologies, which is part of Radiology Partners. Cognita CXR is a vision-language model that analyzes chest X-rays and generates a preliminary report for subsequent review and finalization by a radiologist.
According to preliminary internal clinical data, the use of the model increases the efficiency of image interpretation by 18 percent. It also improves the detection of various findings by 16 to 65 percent.
"We believe this is an important step toward integrating AI into everyday radiology practice, enabling physicians to work at the peak of their capabilities and expanding access to quality imaging worldwide," said Nina Kottler, MD, Chief Medical Officer for AI at Mosaic Clinical Technologies.
The breakthrough device status accelerates interaction with the FDA and aims to address diagnostic throughput challenges. How will this affect the real workload of radiologists in clinics?
The model integrates into existing workflows: radiologists receive a comprehensive preliminary assessment and can focus on final interpretation. The company emphasizes that this is one of the first such tools to receive regulatory recognition.
