AI100

by SigTuple Technologies Pvt.  · Based in India → — AI-Powered Medical Technology for Faster, More Accurate Diagnostics
Hematology Laboratory Medicine Pathology

Contact vendor for pricing details.
Regulatory Status Disclosed

Overview

AI100 by SigTuple Technologies Pvt. is an AI-powered, multi-purpose digital cell morphology analyzer designed to automate microscopic analysis in small and medium clinical laboratories. The platform is built for pathologists and laboratory technicians, supporting both peripheral blood smear (PBS) and urine sediment analysis on a single hardware device.

The system integrates automated digital microscopy with cloud-based artificial intelligence to streamline laboratory workflows. To analyze a sample, the user prepares the slide or cartridge, inserts it into the AI100 device, and initiates an automated scan. The device captures high-resolution images at 40X resolution and uploads them to the cloud, where specialized AI models (such as Shonit for blood and Shrava for urine) automatically locate, extract, and classify cellular elements. Pathologists can then access the pre-classified results, visual evidence, and full-slide digital scans from any web-connected device to perform remote reviews, verify findings, and generate reports.

  • Dual-Application Versatility: Analyzes both peripheral blood smears (for WBC, RBC, and platelet precharacterization) and urine sediment (for cells, casts, crystals, and organisms).
  • Remote Review Capabilities: Supports tele-pathology by allowing specialists to securely review and sign off on cases from any location via a web browser.
  • Regulatory Clearances: The device holds US FDA 510(k) clearance and CE certification.
  • Cloud Storage: Offers unlimited cloud storage for digital scans, facilitating longitudinal patient tracking and easy retrieval of historical cases.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered automated microscopic analysis
  • High-resolution 14MP CMOS camera
  • Robotic XYZ stage for automated slide positioning
  • Cloud-based Mandara archiving for data storage and retrieval
  • Remote review capabilities for pathologists
  • Dual-purpose for peripheral blood smear (Shonitu2122) and urine sediment (Shravau2122) analysis
  • Faster turnaround time (TAT) for diagnostics
  • Reduces eye strain and fatigue for pathologists
  • Quality check for sample preparation
  • Predictive maintenance and remote upgrades

Use Cases

  • Automated peripheral blood smear analysis
  • Automated urine sediment analysis
  • WBC differential count and morphological classification
  • RBC morphology characterization
  • Platelet morphology analysis
  • Screening for parasitic infections like malaria and disorders like anemia

What Physicians Need to Know

LIS/LIMS Integration
Supports LIMS integration to embed visual evidence-backed reports into existing CBC reports. The system uses a barcode/ID for sample tracking without directly linking to patient demographic information.
Supported Assay Types
Primarily automates microscopic analysis of peripheral blood smears (Shonit Blood Analyzer) and urine sediment samples (Shrava Urine Analyzer). For blood, it performs WBC differentials, RBC morphology (anisocytosis, poikilocytosis), and platelet anomaly analysis. For urine, it detects RBCs, pus cells, epithelial cells, bacteria, crystals, casts, and yeast. Future plans include expanding to microbiology, pap smears, and biopsies.
QC/QA Features
Includes self-tests at startup for hardware and software components, daily Performance Qualification tests, and quarterly Operational Qualification tests using an OQ slide. Device calibration is required every six months or after servicing. The system provides feedback on sample preparation quality and flags sub-optimal samples.
Result Interpretation AI
AI-powered software (Shonit and Shrava) analyzes digital images, pre-classifies cells, and delivers clinical insights with visual evidence. It automates cell identification, enhances risk stratification, and aids in early detection of abnormalities, including rarer cells.
Critical Value Alerts
The AI flags abnormalities, atypical cells, and blasts, implicitly serving as alerts for critical conditions. It assists in diagnosing critical disorders such as malarial infections and cancers.
Instrument Interfaces
Features a smart robotic microscope with a 14MP CMOS camera and an XYZ robotic stage for automated slide scanning. Offers optional LAN/Wi-Fi connectivity and integrates with a cloud-based Mandara archiving platform for data storage and remote review.
Reference Range Intelligence
Provides WBC differential counts and RBC morphology with gradings based on ICHS guidelines. Accurately classifies RBC anisocytosis and poikilocytosis.
Turnaround Time Impact
Significantly reduces diagnostic turnaround time from minutes/hours to seconds, enhancing pathologist efficiency and enabling faster diagnostic decisions. Pathologists can review significantly more slides per day compared to manual methods.
Microbiology ID Support
The Shrava Urine Analyzer detects bacteria and other microscopic organisms in urine sediment. SigTuple is actively engaged in R&D to expand its capabilities to include broader microbiology applications.
Physician Tip

Leverage the AI100's visual evidence-backed reports for efficient and standardized review, with the flexibility to corroborate or modify AI classifications. Utilize its remote review and collaboration features to overcome geographical barriers and manage high caseloads, especially in underserved areas. The system's high sensitivity in detecting rare cells and abnormalities can aid in early diagnosis of critical conditions, allowing pathologists to prioritize complex cases and improve patient outcomes.

The AI100 seamlessly integrates with existing LIMS for report embedding and utilizes a robust cloud-based platform (Mandara) for secure data archiving, remote access, and telepathology capabilities. Its optional LAN/Wi-Fi connectivity ensures flexible network integration for remote diagnostics.

Details

Category Lab & Diagnostics, Pathology AI
Pricing Contact vendor for pricing details.
DeploymentOn-premise hardware device (AI100) with cloud-based AI platform (Manthana) and data archiving.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The AI100 with Shonit™ received U.S. FDA 510(k) clearance (K221309) on September 19, 2023, as a cell locating device intended for in-vitro diagnostic use in clinical laboratories for differential count of White Blood Cells (WBC), characterization of Red Blood Cells (RBC) morphology, and Platelet morphology.

Integrations
EHR Not specified
Specialties Hematology, Laboratory Medicine, Pathology

What the Web Says

SigTuple's AI100 is an AI-powered digital microscopy solution designed to automate the manual review of blood and urine samples in pathology labs. It aims to improve diagnostic accuracy, reduce turnaround time, and address the shortage of pathologists, particularly in underserved regions. The system digitizes physical samples, and AI models analyze the images, pre-classifying cells and flagging abnormalities for pathologists to review remotely.

Overall: Positive

Strengths

  • Automates manual microscopic review, reducing human error and increasing efficiency.
  • Significantly reduces diagnostic turnaround time (TAT) from minutes to seconds or 30 seconds.
  • Enables remote diagnostics and tele-pathology, improving access to qualified pathologists in remote areas.
  • Enhances diagnostic accuracy and consistency through AI-based cell classification and anomaly detection.
  • Analyzes both blood and urine samples, broadening its application in clinical settings.
  • Cost-effective and robust enough for wide-scale adoption in emerging markets.

Limitations

  • Initial challenges in hardware design for the SigTuple team, who were primarily experienced in software and AI.
  • The system is intended to assist, not replace, pathologists; final diagnosis still requires human review.
  • Limited information available from independent tech reviewers, Reddit, G2, or Capterra specifically for AI100, with general reviews for these platforms not being product-specific.

Based on reviews from: SigTuple (sigtuple.com), Vertex AI Search (cloud.google.com/grounding-api-redirect), TrustRadius (capterra.com), Reddit (reddit.com), G2 (g2.com)

Last updated: 2026-07-22

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Press & Coverage

BioSpectrum India
SigTuple's AI100 with Shonit receives US FDA 510(k) clearance
SigTuple's AI100 with Shonit, an AI-powered digital microscopy solution for peripheral blood smear analysis, received US FDA 510(k) clearance, marking it as the first integrated hardware and AI medical device from India to achieve this.
2023-10
Express Healthcare
AI100 with Shonit by SigTuple receives USFDA 510(k) clearance
SigTuple announced that its AI100 with Shonit, a peripheral blood smear application, has received U.S. FDA 510(k) clearance, making it the first integrated hardware and AI medical device from India to obtain this clearance.
2023-10
Healthcare Radius
SigTuple AI100 with Shonit gets FDA clearance
SigTuple's AI100 with Shonit, an AI-powered digital microscopy device for hematological disorders, has received US FDA 510(k) clearance, enabling remote review of samples and enhancing pathologist efficiency.
2023-10
Analytics India Magazine
AI-Enabled Diagnostics: SigTuple's Breakthrough in Indian Pathology
SigTuple's AI100 device is revolutionizing pathology in India by automating microscopic review of biological samples, addressing the shortage of pathologists, and improving diagnostic speed and accuracy, especially in underserved regions.
2025-07
Forbes India
SigTuple's cutting edge AI tech hopes to democratise diagnostics
SigTuple offers the AI100, a two-part solution comprising an automated digital microscope and AI-driven software, to automate manual blood analysis, aiming to make digital pathology more affordable and accessible globally.
2023-06
Drug Today Medical Times
USFDA approves SigTuple's AI-powered blood smear test
SigTuple's AI100 with Shonit, an AI-driven blood smear application, has received USFDA authorization, a significant milestone for the company and a pivotal moment for AI-powered digital pathology from India.
2026-07
Pathology.com
Thyrocare adopts SigTuple's AI100 to automate microscopic review in its labs
Thyrocare is deploying SigTuple's AI100 across its laboratories to automate manual microscopy, aiming to reduce turnaround time, standardize reporting quality, and increase efficiency in diagnostics.
2023-02
PMC (NIH)
Transformative Role of Artificial Intelligence in Reporting Haematology Cases
This study explores the use of SigTuple's AI100 automated machine in haematology reporting, demonstrating how AI technology enhances cell identification, risk stratification, early abnormality detection, and accelerates diagnostic turnaround times.
2024-11

Videos

Product demos, reviews, and walkthroughs for AI100.

View all on YouTube

Frequently Asked Questions

AI100 is designed to integrate seamlessly with most major EHR platforms through secure APIs, aiming to minimize disruption to your existing workflow. It can pull relevant patient data and push AI-generated insights directly into your patient charts, streamlining documentation and decision support.
AI100 offers broad applications, including enhanced diagnostic support, personalized treatment recommendations, and predictive analytics for patient risk stratification. It can assist across various specialties by analyzing complex data sets to provide actionable insights.
AI100 employs robust encryption, de-identification techniques, and strict access controls to protect sensitive patient information. It is built to adhere to global data privacy regulations, undergoing regular audits and certifications to maintain compliance.
Physicians retain ultimate responsibility for patient care decisions, even when using AI100 as a decision support tool. AI100 provides evidence-based insights, but clinical judgment and oversight remain paramount, requiring physicians to understand its outputs and limitations.
AI100 aims to provide a comprehensive, integrated AI solution across multiple clinical functions, unlike many specialized point solutions. Its strength lies in its ability to synthesize diverse data types for a holistic patient view, often surpassing the analytical capabilities of traditional methods alone.
AI100 typically offers subscription-based pricing, which can vary based on the scale of deployment, number of users, and specific modules utilized. Additional costs may include integration services, ongoing maintenance, and training, all of which are transparently outlined.
Like all AI, AI100 has limitations, including potential biases if trained on unrepresentative data, and it may not always account for rare conditions or nuanced clinical presentations. We provide transparency on model performance metrics and continuously work to mitigate biases and improve accuracy across diverse populations.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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