Radiology Partners’ AI business receives Breakthrough Device designation from FDA
Radiology Partners’ recently acquired artificial intelligence business, Cognita, has received the Breakthrough Device designation from the U.S. Food and Drug Administration for a key radiograph-related technology.
The country’s largest imaging group announced the news Thursday, with the decision applying to its Cognita Chest X-ray tool across multiple clinical indications. Rad Partners believes this is the industry’s first generative vision-language model—AI that combines computed vision and large language models to decipher content—to assist radiologist in interpreting X-rays.
Based on public information, the AI tool also is one of the first such solutions to earn this label from the FDA. The Breakthrough Program helps to expedite the review of new medical devices that address critical diseases or conditions.
“Breakthrough Device designation marks a significant milestone for Cognita CXR,” Nina Kottler, MD, MS, chief medical officer of Mosaic Clinical Technologies, RP’s technology services division, said in a statement March 5. “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.”
Cognita CXR applies proprietary AI to interpret radiographs and draft preliminary reports for physician review. Different from other AI that focuses on individual findings, the model generates “comprehensive preliminary findings that are fully integrated into existing” workflows. Radiologists are then able to review and finalize the findings, Rad Partners noted.
Early internal validation shows that participating Rad Partners radiologists using Cognita CXR achieved “enhanced detection” of up to 16% to 65% for certain findings. The AI program also has the potential to boost average interpretation efficiency for participating radiologists by 18%. RP noted that Breakthrough Device designation will allow Cognita to collaborate closely with the FDA to help bring this technology to the U.S. market.
Cognita and RP also are working to develop solutions that assist radiologists in interpreting X-rays and 3D CT imaging across all anatomies. Rad Partners first launched its Mosaic division in July and acquired Cognita, which was founded at Stanford University, for $80 million in November. Based in Nashville, Tennessee, Rad Partners employs approximately 4,000 physicians, handles 55 million imaging studies annually, and is partially backed by outside investors.
“Radiology Partners was founded to transform how radiology is practiced and delivered,” Rich Whitney, MBA, co-founder and CEO, said in the announcement. “The Breakthrough Device designation for Cognita reflects our commitment to pairing great physicians with advanced technology to address the growing demand for diagnostic imaging while meaningfully improving the diagnostic value we offer to clients and patients.”
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.