Annalise Enterprise CTB

annalise.ai
Annalise Enterprise CTB is an AI clinical decision-support solution for non-contrast head CT, detecting up to 130 findings.

Features include:
• customisable, interactive viewer that integrates into PACS/RIS
• a confidence bar displaying the likelihood of the finding and uncertainty of the AI model
• worklist triage

**FDA 510(k) clearance as CADt for seven acute findings: acute subdural/epidural hematoma, acute subarachnoid hemorrhage, Intra-axial hemorrhage, intraventricular hemorrhage, obstructive hydrocephalus, vasogenic edema, and mass effect.**
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Information source: Vendor
Last updated: July 9, 2024

General Information

General
Product name Annalise Enterprise CTB
Company annalise.ai
Subspeciality Neuro
Modality CT
Disease targeted 130 findings present in the emergent, urgent, and non-urgent care settings including: Intracranial haemorrhage, haematomas (acute subdural/extradural), fractures, pneumocephalus, infarct, mass effect & midline shift, obstructive hydrocephalus, Intraaxial mass, transependymal oedema, colloid cyst, vasogenic oedema, and many others.
Key-features Detection of up to 130 findings (acute and chronic) on brain CT, worklist triage, notification, visualisation, confidence bar, normal/abnormal differentiation
Suggested use Before: adapting worklist order, flagging acute findings
During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand)

Technical Specifications

Data characteristics
Population All non-contrast head CT studies for patients over 18 years of age
Input Non-contrast CT
Input format DICOM
Output Indication of presence of finding, segmentation overlay, confidence and threshold score/bar
Output format Customizable AI Viewer. DICOM SC. Worklist – HL7 or API based output for worklist triage (prioritisation)
Technology
Integration Integration in standard reading environment (PACS), Integration RIS (Radiological Information System), Integration via AI marketplace or distribution platform, Stand-alone third party application
Deployment Locally on dedicated hardware, Locally virtualized (virtual machine, docker), Cloud-based, Hybrid solution
Trigger for analysis Automatically, right after the image acquisition
Processing time 1 - 10 minutes

Regulatory

Certification
CE
Certified, Class IIb , MDR
FDA 510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE) Annalise Enterprise is a medical device intended to assist clinicians with the interpretation of radiological imaging studies and provide notification of suspected findings.

Market

Market presence
On market since 07-2022
Distribution channels Nuance PIN, Sectra Amplifier, Blackford
Countries present (clinical, non-research use) 40+
Paying clinical customers (institutes) 300+
Research/test users (institutes) 10+
Pricing
Pricing model Subscription
Based on Number of analyses

Evidence

Evidence
Peer reviewed papers on performance

  • Evaluation of an artificial intelligence model for identification of mass effect and vasogenic edema on computed tomography of the head (read)

  • Effects of a comprehensive brain computed tomography deep learning model on radiologist detection accuracy (read)
Non-peer reviewed papers on performance
Other relevant papers