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Products
Mia
Mia
Kheiron Medical Technologies
Mia supports radiologists in making the recall decision in breast cancer screening. Available to use in various configurations such as an independent second reader, a concurrent reader or in double reader triage. It also offers an AI-enabled breast positioning and image quality assurance tool: Mia IQ.
Information source:
Vendor
Last updated:
June 9, 2024
General Information
Technical Specifications
Regulatory
Market
Evidence
General Information
General
Product name
Mia
Company
Kheiron Medical Technologies
Subspeciality
Breast
Modality
Mammography
Disease targeted
Breast cancer
Key-features
Independent second read, recall suggestion, suspicious region marking, image indications
Suggested use
Before: stratifying reading process (non, single, double read)
During: perception aid (prompting all abnormalities/results/heatmaps)
After: diagnosis verification
Technical Specifications
Data characteristics
Population
Mammography screening population
Input
2D Full-Field Digital Mammography
Input format
DICOM
Output
Recall or no recall suggestion, image indications, auxiliary regions of interest
Output format
DICOM Mammography Structured Report or Presentation State
Technology
Integration
Integration in standard reading environment (PACS)
Deployment
Cloud-based, Hybrid solution
Trigger for analysis
Automatically, right after the image acquisition
Processing time
10 - 60 seconds
Regulatory
Certification
CE
Certified, Class IIa
, MDD
FDA
No or not yet
Intended Use Statements
Intended use (according to CE)
Mia is indicated to aid readers in the interpretation of breast imaging examinations for the early detection and diagnosis of breast cancer. The device can serve as a concurrent reader in all reading workflows, including single and/or double reading workflows. Additionally, the device can serve as an independent second or third reader in blinded or unblinded workflows. The device can also be used in the triaging of examinations for workflow prioritisation, and resource management. Output of the device may include classification information such as case-wise suggestion (suspicion of malignancy and/or recommendation that the subject/patient ‘should be recalled’ or ‘should not be recalled’ for further assessment), and localisation information of suspected malignancies such as left and/or right side, projection (e.g. CC and/or MLO views), and region(s) of interest (ROI).
Market
Market presence
On market since
10-2018
Distribution channels
Various
Countries present (clinical, non-research use)
10+
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model
Based on
Evidence
Evidence
Peer reviewed papers on performance
Cost-effectiveness requirements for implementing artificial intelligence technology in the Women’s UK Breast Cancer Screening service
(read)
Prospective implementation of AI-assisted screen reading to improve early detection of breast cancer
(read)
Non-peer reviewed papers on performance
Large-scale evaluation of an AI system as an independent reader for double reading in breast cancer screening
(read)
Other relevant papers
Comparison of Mammography AI Algorithms with a Clinical Risk Model for 5-year Breast Cancer Risk Prediction: An Observational Study
(read)