Artificial intelligence (AI) software developer Lunit has received the Medical Device Single Audit Program (MDSAP) certificate after meeting requirements as a global standard medical AI software manufacturer.
The MDSAP certificate program is overseen by the International Medical Device Regulators Forum, a global audit program that leverages regulatory resources to manage an efficient, effective, and sustainable single audit program, Lunit said. Manufacturers are certified for a single quality management system audit in place of multiple audits by regulatory agencies for five countries, including the U.S., Canada, Japan, Australia, and Brazil.
The certification is considered evidence of a medical device manufacturer's commitment to product quality and regulatory compliance, Lunit said.
Lunit's plans to officially launch its Insight DBT and Lunit Insight Chest CT products this year after highlighting them at RSNA 2021.
![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.auntminnie.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)
