brainTale-care

BrainTale

brainTale-care is a software medical device available in SaaS (Software as a Service) today consisting of two modules:
• The brainQuant module, which enables automatic processing and quality control of brain diffusion MRI and the provision of global and regional standardized parameters.
• The brainScore-coma module, which provides a clinically validated prediction score of coma recovery in two patient populations (comatose after cardiac arrest or trauma brain injuries to date) calculated from the brainQuant regional broadcast standard parameters.

Information source: Vendor
Last updated: April 5, 2022

General Information

General
Product name	brainTale-care
Company	BrainTale
Subspeciality	Neuro
Modality	MR
Disease targeted	Neurological disorders including traumatic brain injury, stroke, cardiac arrest, and neurodegenerative diseases
Key-features	White matter quantification (global and regional), prognosis score for comatose patients after cardiac arrest and traumatic brain injuries
Suggested use	During: perception aid (prompting all abnormalities/results/heatmaps), report suggestion Without interference of a radiologist: AI-only diagnosis

Technical Specifications

Data characteristics
Population	Adults patients with neurological disorders
Input	Diffusion MRI, 3D T1-weighted MRI
Input format	DICOM
Output	Quantified values, prognosis scores, graphs, maps, videos, pdf reports
Output format	Reports (.pdf), figures (.png), videos (*.mp4)
Technology
Integration	Stand-alone webbased
Deployment	Cloud-based
Trigger for analysis	On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time	> 10 minutes

Regulatory

Certification
CE	Certified, Class IIa , MDR
FDA	No or not yet
Intended Use Statements
Intended use (according to CE)

Market

Market presence
On market since	04-2022
Distribution channels
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Pay-per-use, Subscription, One-time license fee
Based on	Number of users, Number of installations, Number of analyses

Evidence

Evidence
Peer reviewed papers on performance
Non-peer reviewed papers on performance
Other relevant papers