annalise.ai Announces FDA 510(k) Clearance for Additional CXR Findings
Update: Annalise.ai is now “Harrison-AI Medical Pty Ltd
annalise.ai has expanded its portfolio of FDA 510(k) cleared findings for chest X-ray to a total of five. We now offer the highest number of findings for triage and notification on chest X-ray in the U.S. market. Cleared chest X-ray findings include:
- Pleural effusion
- Pneumoperitoneum
- Vertebral compression fracture
- Pneumothorax
- Tension pneumothorax
annalise.ai received its first FDA clearance in February 2022 for the triage and notification of pneumothorax on chest X-ray. It is the first product available in the U.S. market to differentiate a tension pneumothorax, allowing a clinical site to apply specific triaging rules for the most urgent tension pneumothorax cases.
This builds on our momentum in the U.S and brings annalise.ai FDA 510(k) cleared findings to a total of nine, including four findings for triage and notification of non-contrast head CTs.
Click here to read the full press release.
About Harrison.ai
Harrison.ai is a global healthcare technology company that enhances clinician capacity and patient care through AI automation. Clinician-led and patient-first, our suite of solutions supports earlier, more accurate diagnoses and seamlessly integrates into clinical workflows.Harrison.ai solutions are available in 40+ countries and to half of all Australian radiologists. They are clinically deployed at 1,000+ customer sites globally, including 40+ NHS Trusts and all public emergency departments in Hong Kong. With 3,400+ clinicians using our tools, Harrison.ai has impacted more than 7 million patients’ lives to date.

