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ClearRead Xray - Detect

Riverain Technologies

ClearRead Detect identifies regions-of-interest on the bone suppressed soft tissue image that may be early-stage lung cancer.

Information source: Vendor
Last updated: June 20, 2022

General Information

General
Product name	ClearRead Xray - Detect
Company	Riverain Technologies
Subspeciality	Chest
Modality	X-ray
Disease targeted	Lung cancer
Key-features	Lung nodule detection of nodules of 9 to 30 mm in size
Suggested use	During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand)

Technical Specifications

Data characteristics
Population	Adult, not pediatric
Input	PA/AP chest view, showing both lungs
Input format	DICOM
Output	Segmentation overlay
Output format	DICOM Secondary Capture
Technology
Integration	Integration in standard reading environment (PACS), Integration via AI marketplace or distribution platform
Deployment	Locally on dedicated hardware, Locally virtualized (virtual machine, docker)
Trigger for analysis	Automatically, right after the image acquisition
Processing time	1 - 10 minutes

Regulatory

Certification
CE	Certified, Class IIa , MDR
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)	ClearRead Xray Detect is a computer-aided detection (CAD) system intended to identify and mark regions of interest (ROIs) on digital or digitized frontal chest radiographs. It identifies features associated with solitary pulmonary nodules from 9 to 30 mm in size, which could represent early-stage lung cancer. The device is intended for use as an aid only after the physician has performed an initial interpretation of the radiograph.

Market

Market presence
On market since	11-2008
Distribution channels	Sectra Amplifier Store, Aidoc aiOS, Volpara Health, GE Healthcare
Countries present (clinical, non-research use)	13
Paying clinical customers (institutes)	200+
Research/test users (institutes)	6
Pricing
Pricing model	Subscription, One-time license fee
Based on	Number of analyses

Evidence

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