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 on a mission to urgently scale healthcare capacity through AI-powered medical imaging diagnostic support and workflow solutions. Its radiology (Annalise.ai) and pathology (Franklin.ai) solutions help clinicians deliver faster, more accurate diagnoses, aiding in the early detection of cancer and other medical conditions. Harrison.ai partners with hospitals and private clinics across APAC, EMEA, the United Kingdom and United States. For more information, visit Harrison.ai.
