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.**

Information source: Vendor
Last updated: Sept. 28, 2023

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