Annalise Enterprise CXR receives first U.S. FDA 510(k) clearance
We are excited to share that we have received the first U.S. FDA 510(k) clearance for our Annalise Enterprise CXR solution.
This CADt FDA clearance is for the triage and notification of pneumothorax on chest X-ray. In addition to triaging pneumothorax, this is the first product to differentiate a tension pneumothorax, allowing a clinical site to apply specific triaging rules for the more urgent tension pneumothorax cases.
This is another testament to our mission of bringing imaging AI solutions to assist clinicians worldwide.
The solution is CE marked for use as a medical device in the EU, and available for clinical use in Australia , New Zealand and Malaysia. Annalise Enterprise is not available for purchase by the general public.
Book a meeting with the team to learn more about Annalise Enterprise and the features available in different regions.
