U.K. ultrasound training and quality assurance firm Intelligent Ultrasound Group has received International Organization for Standardization (ISO) certification for its quality management system.
The ISO13485:2016 certification comes after a review by Lloyd's Register Quality Assurance (LRQA) and validates the company's design, development, production, installation, and sale of medical devices that are safe for use.
Intelligent Ultrasound Group, formerly known as MedaPhor, plans to bring a range of artificial intelligence-based image analysis software to market, which requires ISO13485:2016 certification.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
