Research & Documentation

Access peer-reviewed publications, clinical validation studies, regulatory documents, and technical specifications

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Research Impact

1
Peer-Reviewed Publications
1
Recent Patent Applications
50+
Samples Tested
97.6%
Diagnostic Accuracy
RESEARCH PAPER

Time-Dependent Changes in Serum Biomarker Levels After TBI

Comprehensive study on the temporal profiles of GFAP and UCH-L1 in patients with traumatic brain injury, published in JAMA Neurology.

View on JAMA Network
Published: February 2020 DOI: 10.1001/jamaneurol.2019.4412
RESEARCH PAPER

GFAP and UCH-L1 as Diagnostic Biomarkers for TBI

Multicenter validation study demonstrating the clinical utility of GFAP and UCH-L1 for detecting traumatic brain injuries.

View in The Lancet Neurology
Published: May 2018 DOI: 10.1016/S1474-4422(18)30231-X
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CLINICAL STUDY

Banyan Brain Trauma Indicator Clinical Validation

Clinical validation of the Banyan Brain Trauma Indicator, the first FDA-cleared blood test for evaluating mild traumatic brain injury.

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Published: December 2017 PMID: 29298304
CLINICAL STUDY

GFAP Out-Performs S100β in Detecting Traumatic Intracranial Lesions on CT

Prospective study comparing the diagnostic accuracy of GFAP and S100β in detecting traumatic intracranial lesions on CT scans.

View in Clinical Chemistry
Published: January 2014 DOI: 10.1373/clinchem.2013.211045
REGULATORY

CDSCO Class C Device Registration Dossier

Complete regulatory submission package for CDSCO approval, including device classification, safety data, and manufacturing standards.

PDF • 5.1 MB 2025
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ISO CERTIFICATION

ISO 13485:2016 Quality Management System

Certification demonstrating compliance with international quality standards for medical device design and manufacturing.

PDF • 0.8 MB 2025
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TECHNICAL SPEC

Bio-Stride TBI Analyzer: Technical Specifications

Comprehensive technical documentation including device specifications, performance characteristics, and integration guidelines.

PDF • 2.8 MB 2025
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WHITE PAPER

Electrochemical Biosensor Technology: Principles and Applications in Emergency Diagnostics

Technical white paper explaining the underlying technology, sensor design, and biomarker detection methodology.

PDF • 1.9 MB 2024
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MARKET ANALYSIS

Indian Emergency Diagnostics Market: Opportunities in TBI Detection

Comprehensive market analysis covering TAM, competitive landscape, and growth projections for point-of-care TBI diagnostics in India.

PDF • 3.5 MB 2025
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IMPACT REPORT

Social Impact Assessment: Reducing TBI-Related Disabilities in Rural India

Analysis of potential social and economic impact of widespread TBI detection deployment in underserved communities.

PDF • 2.1 MB 2024
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Key Citations & References