Regulatory Approval

The UltraSightHD Digital Colposcopy System with ImageSense and RemoteView Telemedicine Technologies Brings Significant Technical Innovations to the Practice of Colposcopy

UltraSightHD offers a high-resolution camera system with a fully integrated clinical workflow solution for colposcopy that incorporates DICOM-compliant imagery and a seamless Electronic Medical Records (EMR) interface via its onboard touch-screen user interface.

UltraSightHD Medical Imaging System - Science & Technology International

FDA Cleared

510(k) cleared for United States market. 3 separate FDA clearances available.

CE Mark Approved

European regulatory clearance. Access to EU and CE country markets.

ISO 13485 Certified

Quality management system certified for medical device manufacturing.

Calibrated and Standardized Imagery

Each Image Features True Color, Sharp Focus,
and Archival-Quality Resolution

This calibration and standardization gives the colposcopist confidence of the consistency of the image quality from exam-to-exam, location-to-location and doctor-to-doctor and in quality of the archive imagery obtained over the course of days, weeks, months, and years.

Calibrated and Standardized Colposcopy Imagery — acetowhite lesion mapping with color-coded difference overlays

Intelligent Software ImageSense

Software Guides Doctors to the Biopsy Site

Acetowhite Opacity Viewer produces the Difference Map of the color change before and after the application of Acetic Acid. It tells the doctor if there is a lesion, where is it, how big it is, and how serious the lesion is. Because the workflow follows standard clinical practice, there is very little training required — the operator does not have to be a doctor or nurse. The system can be operated by any trained individual.

94% sensitivity for CIN2+

Clinically validated across 412,000+ screening encounters

87% specificity

Consistent performance across diverse populations

89% Negative Predictive Value

High confidence ruling out disease in negative cases

Acetowhite lesion detection: Pre-Aceto, Post-Aceto, and Difference Map panels showing acetowhite change mapping

RemoteViewer Telemedicine

Immediate Results from Anywhere in the World

UltraSightHD RemoteViewer enables real-time transmission of image data to specialist physicians, radiologists, and pathologists — dramatically expanding access to expert diagnostic interpretation across geographies.

Real-time image streaming

Low-latency HD image transmission

HIPAA-compliant cloud architecture

Enterprise-grade security and data privacy

Works only for UltraSightHD

Browser-based — accesible anywhere in the world with internet

Clinical Validation

How UltraSightHD Compares

Objective performance data across key diagnostic metrics — cleared by regulatory bodies in the United States and Europe.

Diagnostic Capability	UltraSightHD	Conventional Colposcopy	Consumer Adapters
Sensitivity for CIN2+	94%	70–80%	~40%
Specificity	87%	64–76%	~50%
Negative Predictive Value	89%	50–65%	~35%
Remote Specialist Access	✓	—	—
Reimbursement Eligibility	✓	✓	—
Regulatory Approvals	3 FDA / 2 CE	Varies	—