BOSTON–a2z Radiology AI Inc. has received certification under the European Union’s Medical Device Regulation (MDR) for its artificial intelligence software, a2z-Drafter, which can detect 182 radiological findings across CT scans of the head, chest, abdomen and pelvis.
The certification allows the company to introduce the software to radiology providers in the European Union, where it can be used to support medical imaging triage, detection of abnormalities and preparation of draft radiology reports.
According to the company, a2z-Drafter is the first AI product certified under the EU MDR to combine detection and report drafting capabilities across all four anatomical regions within a single platform.
“Radiology teams have had to piece together separate AI tools for each condition and body region,” said Samir Rajpurkar, Co-Founder and Chief Executive Officer of a2z Radiology AI. “a2z-Drafter is one product that works on head, chest and abdomen-pelvis CT scans and gives the radiologist a structured starting point for the report. This certification lets us bring that to radiology teams in the European Union.”
The software analyzes CT images to identify 182 validated radiological findings, ranging from potentially life-threatening conditions to abnormalities requiring routine follow-up.
Among the acute conditions the system can detect are subarachnoid hemorrhage, midline shift, pneumothorax and bowel obstruction. It can also identify findings that may require further medical evaluation, including obstructing ureteral stones and aortic aneurysms.
Each detected finding is assigned a priority category that healthcare providers can use to organize imaging studies and identify cases that may require more immediate attention.
The platform also generates structured information that can be incorporated into draft radiology reports, allowing physicians to review the identified findings and prepare their final interpretations.
a2z-Drafter is designed to integrate with existing Picture Archiving and Communication Systems (PACS), Radiology Information Systems (RIS) and clinical worklist platforms, enabling radiologists to use the technology within their established workflows.
The software supports CT studies performed with or without contrast in adults aged 18 and older.
Despite its automated detection and reporting capabilities, the system is intended to assist rather than replace radiologists. Physicians must independently examine the complete imaging study and remain responsible for the final diagnosis and clinical decisions.
“A single CT scan can reveal an acute finding that needs urgent attention alongside several that require routine follow-up,” said Jeff Brown, M.D., Radiologist and Chief Medical Officer of a2z Radiology AI. “a2z-Drafter assigns each detected finding a priority category within the radiologist’s existing workflow. The radiologist still reviews the entire study and is responsible for the final interpretation.”
The certification represents a development in the use of generalist artificial intelligence for medical imaging, an approach that seeks to identify numerous conditions across multiple anatomical regions rather than relying on separate algorithms for individual abnormalities.
Pranav Rajpurkar, Co-Founder of a2z Radiology AI and Associate Professor of Biomedical Informatics at Harvard Medical School, said the technology reflects years of research into broader clinical applications of AI.
“Generalist AI, one product that covers many findings across the body, has been a research goal for years,” Rajpurkar said. “With this certification, it is a regulated clinical product. Each finding was evaluated on its own against acceptance criteria set in advance, across the head, chest, abdomen and pelvis.”
The company said all 182 findings were evaluated individually against predefined acceptance criteria as part of the product’s validation process.
a2z-Drafter received certification as a Class IIb medical device under the EU Medical Device Regulation from notified body Scarlet NB B.V. (NB 3022).
The certification enables the company to pursue commercial deployment among European radiology providers.
In the United States, a2z-Drafter has not received clearance from the Food and Drug Administration and is not commercially available.
