AIBRIEF
Trained on 780,000+ triple labelled studies, the model sits inside existing clinical infrastructure as decision support, holding the EU's Class IIb medical device mark — the second highest of four EU MDR classes, though Telefónica and Harrison.
Telefónica Tech, the enterprise unit of Spain's largest telco, and Australia's Harrison.ai are installing a CE IIb-marked chest X-ray reader inside Spain's regional public-health networks as decision support, with a radiologist still making the call.
The model was trained on more than 780,000 chest X-ray studies, each independently labelled by at least three qualified radiologists, and is tuned to flag up to 124 clinical findings per scan, including pulmonary nodules relevant to lung cancer screening. Telefónica's AI and data specialists are integrating the system into existing clinical infrastructure, and the company is also handling managed maintenance and technical support.
The algorithm holds CE IIb under EU medical-device rules, a class the Telefónica press release and press room announcement describe as the highest level of assurance for diagnostic support tools. Under EU MDR, Class III sits above IIb, so the "highest tier" framing is a company characterisation. The product itself has an independent anchor: Australia's TGA registers Harrison-AI Medical Pty Ltd as the sponsor of an X-ray image interpretive software.
The company says it is already offering the solution to several regional health services, without naming the autonomous communities. Carlos Martínez, Telefónica Tech's head of data and AI, framed the move as AI becoming an ally of healthcare professionals in delivering faster, more accurate and personalised care.
The next question is operational: whether Spain's regional public-health services can absorb and maintain such tools over time. No prospective performance data from the Spanish deployment is cited, so any reading-time claim should wait for sensitivity, specificity, and turnaround numbers from the installed sites.