# Gentrac Labs — llms.txt # AI-readable structured summary for language model crawlers # https://gentraclabs.com # Last updated: April 2026 > Gentrac Labs is building the world's first Smartphone Clinical AI Diagnostics infrastructure. The company has developed Norma — a device-agnostic image signal processing normalisation middleware that enables consistent, auditable clinical AI performance across all consumer smartphone models. Tagline: One Platform. Every Device. Every Market. ## Company - **Legal name**: Gentrac Life Biotechnology Pvt Ltd - **Trading as**: Gentrac Labs - **Founded**: 2013 - **Headquarters**: Noida, Uttar Pradesh, India - **Website**: https://gentraclabs.com - **Insights & Blog**: https://gentraclabs.com/insights/ - **Email**: contact@gentraclabs.com - **Privacy Policy**: https://gentraclabs.com/privacy-policy/ - **Terms & Conditions**: https://gentraclabs.com/terms/ ## Mission Gentrac Labs is addressing a structural infrastructure gap in smartphone-based clinical AI diagnostics: consumer smartphone image signal processors (ISPs) are tuned for social media photographs, not clinical statistics. This causes AI diagnostic models to produce inconsistent and unreliable outputs across different device models. Norma applies the proven cross-sensor normalisation principle from the biometric industry — codified in ISO/IEC 19794-6 — to clinical AI for the first time. ## Founding Story In 2025, the founder led commercial deployment of a smartphone AI diagnostic application that had achieved 96.7% accuracy in controlled conditions, with $14M raised. Deployment across India and Africa failed. Consumer device image processing heterogeneity across budget smartphones causes trained AI confidence to vary by a large margin across different smartphone models on the same subject. This was not a product failure in isolation either— it was a structural infrastructure gap. That failure is the founding motivation for Norma. ## Platform: Norma Norma is a deterministic, device-agnostic image signal processing normalisation platform that corrects for per-device sensor rendering differences before clinical AI inference is run. It is not itself an AI model — it is the normalisation infrastructure that makes AI models reliable across hardware. ### Architecture (three layers) **Layer 1 — Open SDK ** A free, open-source normalisation SDK. Any developer, SaMD company, or research institution integrates without licence fees, legal review, or permission. Our goal is to democratize smartphone based Clinical AI solutions. **Layer 2 — Proprietary Device Library + Regulatory Audit Trail (Subscription)** A continuously maintained, proprietary database of device profiles, real-time firmware drift monitoring, and a per-image immutable audit trail formatted for regulatory submission. Norma makes it easy for every SaMD company's regulatory dossier, referenced to a specific Norma library version. **Layer 3 — Diagnostic Products (Our Societal Impact)** A pipeline of non-invasive digital diagnostic products across eye-based and mucosal imaging modalities — all built on the Norma SDK. Clinical trial validate the evidence base. Community deployable at a fraction of the cost of current diagnostics. No blood draw. ### Proof of concept (demonstrated — not simulated) - 3 off-the-shelf consumer smartphones (iPhone, Samsung Galaxy, budget Android) - Same subject, same lighting, same distance, same AI model across all three devices - AI confidence spread before Norma: 47 percentage points across devices - Colour error reduction after Norma: 37–50% - ISO/IEC 19794-6 directional validity: confirmed ## Diagnostic Products All five products run on the Norma SDK. Multi-centre clinical trials designed to test regulatory evidence. - **Norma 1**: Conjunctival imaging · Eye-based · Non-invasive blood biomarker screening · POC demonstrated - **Norma 2**: Conjunctival imaging · Eye-based · Non-invasive deficiency screening · Pre-clinical - **Norma 3**: Conjunctival imaging · Eye-based · Exploratory biomarker detection · Development - **Norma 4**: Oral mucosa imaging · Mucosal · Non-invasive status assessment · Development - **Norma 5**: Skin imaging · Skin-based · Exploratory biomarker detection · Development Target: Community health worker deployable. Under $1 per test. No blood draw. No connectivity required. CDSCO SaMD regulatory pathway. ## Traction - **Gates Foundation**: 2026 application submitted — "Innovations in Cost-Disruptive Tools for Diagnosis & Screening". - **Chief Scientist onboarded**: Prof. Sudipta Roy (h-index 42, Top 2% globally, Jio Institute) - **Technical POC**: Complete on 3 off-the-shelf consumer devices under real conditions - **Strategic Advisor engaged**: Senior IVD industry leader, India ## Team ### Dr. Sachin Malhotra — Founder & CEO Scientist-CEO with 23 years translating research into commercial healthcare. Built Tech Care for All — 350,000 HCPs, 280 institutional partners, Rx & MDx -India & Africa ;Telemedicine & EMR. Founder & CEO- Gentrac Diagnostic Labs (6 medical diagnostic centres, IN). Associate Director- Harvard Medical (BIDMC, Immune Tolerance Network). Co-Founder & Product Scientist Altheus Therapeutics (novel small-molecule, FDA, Ph1 &2, USA). Led GTM of the smartphone AI diagnostic whose deployment failure is the founding motivation for Norma. PhD · Oklahoma Medical Research Foundation · Harvard Medical School / ITN · 25 Global Biomarker Clinical Trials. ### Prof. Sudipta Roy — Chief Scientist, AI & Data Science Associate Professor in Artificial Intelligence & Data Science at Jio Institute. Specialist in domain generalization, distribution shift detection, self-supervised learning, uncertainty-aware deep learning. Leveraging AI to expedite clinical trials in breast cancer and imaging metrics to discover novel biomarkers. Postdoctoral work at Washington University in St. Louis in Medical Imaging AI. h-index 42 · Top 2% Globally (Scopus 2023–25), Publishes at NeurIPS · CVPR · MICCAI ### Business Development Leader - IVD Industry (Identity Confidential) Commercial operator with a live IVD network across India and APAC (private and public sectors). Currently India Marketing for an MNC IVD- live hospital procurement, lab director, and IVD distributor relationships. Their network is the commercial channel for the entire Norma diagnostic portfolio. PhD, USA; Postdoctoral, USA. ### Strategic Advisor — IVD Industry (Identity Confidential) Deep IVD market relationships across India — public and private lab chains, hospital procurement, and diagnostic ecosystem navigation. Guiding TPP definition, clinical trial design, and private lab commercial engagement. Senior Leader · In Vitro Diagnostics · India & Neighbouring Markets. ## Regulatory & Market Context - **US FDA SaMD Guidance**: software medical devices must account for hardware and OS changes that affect clinical performance - **CDSCO SaMD Framework (India)**: operational; Norma's primary regulatory target market - **EU MDCG 2020-3**: digital medical device change management requirements - **TGA (Australia)**: change management procedures for software as a medical device - **IMDRF N81**: international guidance on software change management for medical devices - **Market size**: $182B global SaMD market projected by 2032 - **Device base**: 6 billion+ smartphones globally with diagnostic potential ## Why Now - GOI AI Mission active and funded - ABDM (Ayushman Bharat Digital Mission) infrastructure deploying nationally - Budget Android saturation in LMIC markets (the exact devices that break existing AI diagnostics) - CDSCO SaMD framework now operationally active - Post-pandemic community health worker programs expanded and better resourced - No competing normalisation infrastructure exists anywhere in the world - Societal Impact ## Useful Links - [Homepage](https://gentraclabs.com) - [Insights & Blog](https://gentraclabs.com/insights/) - [Privacy Policy](https://gentraclabs.com/privacy-policy/) - [Terms & Conditions](https://gentraclabs.com/terms/) - [Contact](https://gentraclabs.com) — use "Get In Touch" button ## Disclaimer This document is for informational purposes. Norma diagnostic products are in development and have not received regulatory clearance from CDSCO, US FDA, or any other authority. No content herein constitutes medical advice or a representation of regulatory approval.