CerviCARE AI

by NTL Healthcare — AI-powered cervical cancer screening system for early detection.

Regulatory Status Disclosed

Overview

CerviCARE AI is an AI-powered cervical cancer screening system developed by NTL Healthcare. It integrates deep learning algorithms trained on extensive clinical data and expert input from gynecologic oncology specialists to analyze cervical images and predict findings. The system aims to reduce variability caused by subjective interpretation and provide standardized analytical results to support clinical decision-making. CerviCARE AI is designed for point-of-care use, offering rapid analysis (within approximately five seconds) and high diagnostic accuracy, comparable to tertiary-level medical institutions. It is particularly focused on improving access to cervical cancer screening in low- and middle-income countries (LMICs) and medically underserved regions due to its on-device AI processing, which eliminates the need for external network connections and ensures data security by keeping patient data on the device.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered image analysis of the cervix
  • On-device AI processing for offline operation
  • Rapid results in approximately five seconds
  • High sensitivity (98%) and specificity (95.5%) for high-grade lesions
  • Data security with patient data remaining on the device
  • Supports clinical decision-making for cervical screening
  • Ergonomic design and simple interface for image capture
  • AI-assisted image capture guidance and quality assessment
  • DICOM file generation (on-premises version)
  • Tele-health system for expert consultation

Use Cases

  • Early detection of cervical cancer and precancerous lesions
  • Cervical cancer screening in low-resource settings and remote areas
  • Point-of-care diagnostics in primary care and mobile screening centers
  • Supporting healthcare professionals in screening decisions and training
  • Integration into national and regional cervical cancer screening programs
  • Reducing variability caused by subjective interpretation in cervical examinations

Details

Category N/A
Pricing Unknown — unknown
DeploymentSaaS, On-premises (CerviCARE AI AT)
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated

CerviCARE AI received Class III medical device approval from South Korea's Ministry of Food and Drug Safety (MFDS) in April 2026, making it the first embedded, on-device AI diagnostic in the OB/GYN field under the country's Digital Medical Products Act. It also obtained Class 3 medical device approval from the Thai FDA. The Korea Medical Devices Association (KMDA) also lists FDA and MDD/MDR certifications for CerviCARE AI.

Integrations
EHR Not specified
Specialties All specialties

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Suggest an Edit → | Last Verified: 2026-10-16 | First Added: 2026-10-16
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