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CDSCO Approved Medical Device

Comprehensive Cardiac
Autonomic Neurofunction Testing System

CDSCO Class B medical device registration badge
NIBRA-CS® Autonomic Function Testing Device

NIBRA-CS® — Non-Invasive Autonomic Function Testing System

A comprehensive autonomic function testing platform for evaluating parasympathetic and sympathetic responses using standardized cardiovascular reflex protocols — designed for clinical accuracy and ease of use.

Standalone Supported by DBT, GoI Patented Point of Care Testing Touchscreen GUI
Clinical Challenge

Autonomic Dysfunction is Often Underdiagnosed

Autonomic nervous system dysfunction is a significant clinical concern across multiple medical disciplines. Early detection and accurate assessment are essential for effective patient management.

Diabetes mellitus with autonomic neuropathy
Unexplained syncope and orthostatic intolerance
Cardiovascular autonomic dysfunction
Neurodegenerative disorders affecting ANS
Autonomic dysfunction clinical challenge
NIBRA-CS® solution overview
The Solution

A Complete Autonomic Testing Platform

NIBRA-CS® brings complete autonomic function assessment to the point of care — no specialist operator required, no invasive instrumentation, standardised clinical reports whether you run the full diagnostic battery or a rapid HRV screen. It is a patented, standalone device built for real clinical throughput in hospitals, diagnostic centres, and specialty clinics.

The system integrates ECG and non-invasive blood pressure monitoring with a guided clinical workflow and touchscreen interface — enabling a trained technician to conduct the full test battery and generate a clinician-ready report without additional specialist involvement.

Standardised autonomic reflex tests

6 validated tests across parasympathetic, sympathetic, and HRV domains

Integrated ECG and NIBP monitoring

Simultaneous multi-parameter acquisition with real-time signal feedback

Guided clinical testing workflow

Touchscreen interface walks the operator through each protocol step

Automated digital report generation

Structured, scored reports ready for direct inclusion in patient records

Clinical Validation

Validated Across Leading Institutions

NIBRA-CS® has been deployed and evaluated in paid clinical pilots at nationally recognised medical colleges and teaching hospitals.

800+
Patients Evaluated
5+
Institutions
Multi
Ethics Approvals
1st
Commercial Unit at RIMS
AIIMS Kalyani

AIIMS, Kalyani

All India Institute of Medical Sciences

Clinical validation study conducted at AIIMS Kalyani — one of India's premier public medical institutions — establishing the clinical evidence base for NIBRA-CS®.

Medinipur Medical College

MMCH, Midnapore

Medinipur Medical College & Hospital

Paid clinical pilot successfully completed with 300+ patients tested — demonstrating real-world clinical throughput and institutional readiness at scale.

RIMS Ranchi

RIMS, Ranchi

Rajendra Institute of Medical Sciences

First commercial unit deployed at RIMS Ranchi. PHC-level screening integration currently underway — marking the transition from clinical validation to active institutional deployment.

JIMS Budge Budge

JIMS, Budge Budge

Jagannath Gupta Institute of Medical Sciences

Clinical pilots conducted with institutional ethics approval, contributing multi-site validation data for the autonomic assessment protocol.

IIMC Sonarpur

IIMC, Sonarpur

Institute for Indian Mother & Child Hospital

Clinical pilots conducted at IIMC, Sonarpur, extending the validation dataset across diverse patient populations in the greater Kolkata region.

Multi-Institutional Ethics Approval

Institutional Ethics Committee approvals secured across more than 5 distinct organisations — a prerequisite for rigorous clinical data and a signal of institutional trust.

Clinical Assessment Protocol

Tests Supported

NIBRA-CS® digitizes Ewing's Battery of Cardiac Autonomic Function Tests with standardized workflows, automated calculations and integrated HRV analysis.

Select Per Patient

Two Ways to Test

The operator selects one mode on the device at the start of each session. Within either mode, the sequence is fixed and guided automatically — the operator doesn't pick individual tests.

Full Test Battery

7 Elements

The complete autonomic work-up — Ewing's six-test battery plus the 5-minute HRV recording, run in one fixed sequence. Produces a full CAN (Cardiac Autonomic Neuropathy) diagnosis.

  1. 1 Resting
  2. 2 Deep Breathing
  3. 3 Response to Standing
  4. 4 Valsalva Maneuver
  5. 5 Five-Minute HRV Recording
  6. 6 Postural Hypotension
  7. 7 Sustained Handgrip
Duration 19 minutes + prep time
Report 6 pages — full CAN + HRV grading

Short Test

HRV Screening

A single passive 5-minute HRV recording — no active maneuvers, no BP cuff, Valsalva assembly, or handgrip dynamometer required. Ideal for rapid screening, follow-up visits, or patients who cannot safely perform the Full Test Battery's active maneuvers.

Five-Minute HRV Recording

Passive recording — patient rests quietly, no coaching required

Duration 5 min + prep time
Report 3 pages — HRV status only

A Short Test can always be followed by a Full Test Battery at a later visit if the HRV screen indicates further assessment is warranted.

Resting

Resting ECG acquisition before autonomic assessment.

Parasympathetic — 3 Tests

Deep Breathing

Evaluates vagal activity using the E:I ratio during six controlled breathing cycles.

Response to Standing

Calculates the 30:15 ratio to assess parasympathetic response following active standing.

Valsalva Maneuver

Measures autonomic reflex integrity using the Valsalva ratio with guided respiratory maneuver.

Sympathetic — 2 Tests

Postural Hypotension

Measures the fall in systolic blood pressure on standing to assess sympathetic vasomotor response and orthostatic tolerance.

Sustained Handgrip

Assesses the diastolic blood pressure rise during sustained isometric exercise, reflecting sympathetic pressor reserve.

5-Minute HRV — 2 Analyses

Time Domain Analysis

Reports SDNN and RMSSD from beat-to-beat interval variation, reflecting overall autonomic modulation of heart rate.

Frequency Domain Analysis

Computes LF/HF ratio and spectral power to distinguish sympathetic and parasympathetic contributions to heart rate variability.

Automated Reporting

Clinician-Ready Reports, Automatically Generated

NIBRA-CS® generates a structured autonomic assessment report at the close of each test session — including all scored reflex indices, HRV parameters, and an interpretation guide — formatted for direct inclusion in patient records.

Reports are structured to be compatible with standard clinical documentation workflows. No manual data entry, no third-party software required.

CAN Diagnostic Staging

Full Test reports include a Normal / Early / Definite / Severe CAN classification, combined with HRV status into a Final Interpretation — for the referring physician to review and confirm.

Standardised Report Format

Consistent, scored output for every test session — reproducible across operators and settings.

Full HRV Analysis Included

Time Domain (SDNN, RMSSD), Frequency Domain (LF/HF ratio, spectral power), and Poincaré plot parameters reported.

Cardiovascular Reflex Indices

Valsalva ratio, 30:15 ratio, E:I ratio, and BP response scores — all reported and scored per international reference ranges.

Full Test Report — 6 pages
Short Test Report — 3 pages, HRV status only

Reports provide supportive physiological assessment data for clinical review — every report includes a blank Doctor's Comments field, and final diagnosis remains the responsibility of the referring physician.

Compare Past Reports — Report Comparison Tool →
NIBRA-CS® automated clinical report
Clinical Workflow

From Patient Setup to Final Report

NIBRA-CS® standardizes every stage of autonomic function testing through an intuitive guided workflow.

01

Attach Sensors

Connect ECG electrodes and the non-invasive blood pressure cuff using standard clinical consumables.

02

Patient Setup

Verify signal quality and acquire baseline ECG and blood pressure before initiating the protocol.

03

Perform Tests

Guided on-screen instructions lead the operator through parasympathetic, sympathetic and HRV assessments.

04

Generate Report

Automated analysis produces a comprehensive clinical report with autonomic indices, HRV metrics and interpretation guidance.

Use Cases

Clinical Applications Across Specialties

NIBRA-CS® supports standardised autonomic function assessment across multiple clinical departments, enabling early diagnosis, longitudinal monitoring, and evidence-based research.

Endocrinology

Diabetic Autonomic Neuropathy

Enables early detection of cardiac autonomic neuropathy (CAN) and supports standardised follow-up of diabetic patients through repeatable autonomic function testing.

Early CAN Screening
Disease Progression
Therapy Monitoring
Diabetes Clinics
Cardiology

Cardiovascular Autonomic Assessment

Assesses autonomic dysfunction associated with cardiovascular disease, supporting baroreflex evaluation, preventive cardiology, and risk stratification.

Baroreflex Assessment
Risk Stratification
Preventive Cardiology
HRV Evaluation
Neurology

Syncope & Dysautonomia

Evaluates cardiovascular reflex responses to support the assessment of unexplained syncope, autonomic dysfunction, and neurocardiogenic disorders.

Syncope Evaluation
Dysautonomia Assessment
Reflex Testing
Clinical Decision Support
Clinical Research

Research & Clinical Trials

Standardised protocols, digital reports, and reproducible autonomic testing support longitudinal studies, epidemiological research, and multicentre clinical trials.

Longitudinal Studies
HRV Research
Clinical Trials
Digital Data Export
For Institutions

Procuring for Your Hospital or Department?

NIBRA-CS® is CDSCO licensed, Made in India, and procurement-ready for government and private institutional purchase. Every deployment includes on-site installation, staff training, and ongoing technical support.

Whether you are evaluating for a single department or planning a multi-centre rollout, our team will work with your biomedical, clinical, and purchase committees to provide the documentation, demonstrations, and pricing you need to make an informed decision.

CDSCO licensed — regulatory clearance for institutional purchase in India
On-site installation, operator training, and commissioning included
Full procurement documentation available on request

Suitable for

Hospitals

Inpatient and outpatient autonomic testing departments

Neurology Clinics

Specialised autonomic function assessment

Diabetes Centres

CAN screening and longitudinal neuropathy monitoring

Research Institutions

ANS research studies and clinical trials

Medical Colleges

Clinical training and academic autonomic function programmes

Diagnostic Centres

Point-of-care autonomic testing as a standalone service

Official Documentation

Procurement Documentation

Regulatory approvals, patents and institutional documents supporting procurement, compliance and clinical evaluation.

Granted Patent Certificate
Patent

Granted Patent Certificate

Details

Granted patents protecting the core autonomic assessment methodology and device architecture.

View Document →
CDSCO Manufacturing Licence
Regulatory

CDSCO Manufacturing Licence

Details

Regulatory approval authorising manufacture and commercialization of the medical device in India.

View Document →
BIRAC Grant
Grant

BIRAC / DBT Grant

Details

Innovation grant from the Department of Biotechnology supporting clinical development of NIBRA-CS®.

View Document →
IIM Calcutta Innovation Park
Incubation

IIM Calcutta Innovation Park

Details

Official incubation and innovation support through one of India's leading technology incubation centres.

View Document →
In the Field

System in Clinical Use

NIBRA-CS® deployed across clinical institutions and national healthcare events.

CAN Testing at IIMC, Kolkata

CAN Testing — IIMC, Kolkata

World Diabetes Day 2025

World Diabetes Day 2025

TIDE 2.0 Pravartan

TIDE 2.0 Pravartan — New Delhi

Pilot Testing at JIMSH

Pilot Testing — JIMSH

School of Tropical Medicine

School of Tropical Medicine

Global Bio India Launch

Launch — Global Bio India 2023

CDSCO MD5 Approval

CDSCO MD5 Approval

Meeting with MeitY Joint Secretary

With MeitY Joint Secretary — March 2026

Backing & Recognition

Institutional Backing & Funding

Recognised and funded by leading national science, technology, and innovation bodies across India.

Get in Touch

Request a Demonstration or Institutional Enquiry

Contact our team to schedule a product demonstration or discuss deployment for your institution.

Institutional Enquiry

Demonstration requests, procurement evaluation, pilot deployment, and clinical collaboration. Direct line: [email protected]

We respond to institutional enquiries within 48 hours.

Based in Kolkata, India

Incubated at IIM Calcutta Innovation Park. Serving institutions across India.

Registered address: 377, Purbalok, Mukundapur
Kolkata – 700099, West Bengal, India