AI-Based Decision Support for Non-Contrast Head CT Receives CE Mark and Singapore Approval

Annalise.ai has received CE Marking as a class IIb under EU Medical Device Regulation (EU MDR) and Singapore regulatory approvals for its Annalise Enterprise CTB for interpreting non-contrast head CT studies. These certifications extend to the chest X-ray solution Annalise Enterprise CXR, highlighting the company's commitment to delivering cutting-edge AI technology to global healthcare markets through its comprehensive Enterprise AI platform.

"These regulatory approvals demonstrate our commitment to delivering top-quality, compliant, and innovative AI solutions to our valued customers and prospects. We are excited to enter the EU and Singapore markets. This is a significant step forward in our mission to improve patient outcomes globally through AI-driven healthcare," said Lakshmi Gudapakkam, CEO of Annalise.ai.

Annalise Enterprise CTB detects up to 130 radiological findings on non-contrast CT Brain (NCCTB) studies, including a wide range of conditions that require rapid intervention. It has been shown to improve diagnostic accuracy by 32%, averaged across all analyzed findings. Annalise Enterprise CXR can detect up to 124 findings on chest X-rays in under 20 seconds. It has been shown to improve accuracy by 45%, averaged across all analyzed findings. The solutions allow worklist prioritization which supports reporting workflow efficiency by marking critical or unremarkable cases, according to clinical needs.