Annalise.ai has received multiple regulatory approvals for its AI-based decision-support solution, Annalise Enterprise CTB, for interpreting non-contrast head CT studies.
Annalise Enterprise CTB has been granted the CE mark approval under EU Medical Device Regulation (EU MDR) and has also been approved for clinical use in Singapore.
The device can detect up to 130 radiological findings on non-contrast CT Brain (NCCTB) studies and improve diagnostic accuracy by 32%.
Also, the approvals extend to Annalise Enterprise CXR, the chest X-ray solution that can detect up to 124 findings, within 20 seconds, and can improve accuracy by 45%.
The two solutions enable worklist prioritisation that supports workflow reporting by marking critical or ordinary cases, according to clinical needs, said the company.
Annalise.ai CEO Lakshmi Gudapakkam said: “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.”
Annalise.ai said that the latest regulatory approvals add to its growing list that has rapidly been expanding its global footprint since its inception in 2020.
Its Annalise Enterprise solutions are used in public and private healthcare in Australia, the UK, the US, and throughout South East Asia.
The company anticipates additional approvals, as it aims to raise the standard of healthcare with advanced, clinician-friendly AI technology.
