Cognita has received the US Food and Drug Administration (FDA) breakthrough device designation for the Chest X-Ray (CXR) model across multiple critical indications.
Cognita operates as the AI division of Mosaic Clinical Technologies, focused on generative vision-language models for radiology.
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The CXR model is designed to support radiologists in interpreting chest X-rays.
Cognita CXR applies a vision-language model to analyse chest X-rays and generate preliminary radiology findings, which are reviewed and finalised by licensed radiologists. This approach differs from conventional imaging AI systems by producing comprehensive findings integrated directly into existing radiology workflows.
Preliminary internal clinical validation suggests that Cognita CXR may enhance detection rates and increase workflow capacity.
Internal studies indicated that participating radiologists saw improved detection for certain significant findings by 16% to 65%, highlighting its potential for improving diagnostic accuracy. Additionally, the average interpretation efficiency of users reportedly increased by 18%.
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By GlobalDataThe FDA’s breakthrough device programme supports technologies with potential for significant impact on life-threatening or irreversibly debilitating conditions. This programme enables prioritised interactions with the regulator, which can expedite development and regulatory review.
Mosaic expects this collaboration to help address diagnostic capacity constraints in the US healthcare system.
Mosaic Clinical Technologies’ chief medical AI officer Dr Nina Kottler said: “Breakthrough device designation marks a significant milestone for Cognita CXR. It reflects the urgency of the capacity crisis in radiology and provides the opportunity to work closely with the FDA as we advance through the regulatory process.
“We believe this is an important step toward bringing AI into everyday radiology practice in a way that enables physicians to practise at the top of their licence and expands access to high-quality imaging care worldwide.”
