BreastNegative

BreastNegative – The AI That Accelerates and Optimizes Mammographic Screening

BreastNegative is the solution developed by Health Triage to optimize breast cancer screening programs. It uses neural networks based on deep learning models trained on millions of real images and validated by independent scientific institutions.

The system was born from the collaboration between Health Triage and researchers from the Department of Automatic Control and Computer Engineering at Politecnico di Torino. The goal is to improve the quality of oncological prevention through reliable, certified technology that integrates seamlessly into clinical workflows.

A concrete answer to the limitations of traditional screening

Over 99% of screening mammograms turn out to be negative. A reassuring figure for women, but one that leads to inefficient use of medical resources — in a system already marked by a shortage of radiologists and significant regional disparities in access to prevention programs.

This is where BreastNegative comes in: it automatically analyzes every mammogram and identifies with high accuracy those exams showing no suspicious findings. Mammograms classified as definitively negative, according to validated clinical criteria, are reviewed by a single radiologist instead of two, freeing up resources that can be redirected toward expanding existing screening programs and/or managing particularly complex cases.

What sets it apart from other AI systems

Not just detecting tumors, but safely ruling out healthy cases

Unlike most AI solutions for mammography, which focus on identifying lesions, BreastNegative was designed to reliably recognize negative cases.

This approach makes it possible to:

  • increase the operational efficiency of screening centers;
  • optimize the use of radiological resources;
  • improve coverage of prevention programs.

BreastNegative: support for breast diagnostics with intelligent triage and negativity assessment

BreastNegative, an AI-based software medical device, is intended for use by medical professionals — specifically radiologists specialized in breast imaging — to support the clinical evaluation of mammographic exams.

The device takes a complete mammographic exam as input and, by analyzing the radiological images, provides a negativity classification output that categorizes the exam result into three classes:

  • Negative: the analyzed exam shows no signs of breast cancer.
  • Double reading needed: the device cannot determine whether a tumor is present or absent.
  • Not processable: the device was unable to process the exam.

In a mammographic screening context based on double-blind reading, the “Negative” output is designed to support clinical workflow optimization by reducing the need for a second reading by breast radiologists. When the output is “Double reading needed”, the exam is referred back to standard clinical practice.

⚠️ The software does not formulate diagnoses autonomously, nor does it replace clinical judgment. The responsibility for the diagnostic decision and the final report remains exclusively with the specialist physician.

European MDR 2017/745 Certification

BreastNegative is a Class IIb medical device, certified under the European MDR Regulation (EU 2017/745). The certification, issued by Scarlet B.V. (Notified Body no. 3022), confirms that the software meets the highest standards of safety, efficacy, and quality required for medical devices intended for professional use in clinical settings.

Read the MDR certification

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BREASTnegative.ai

The BREASTnegative.ai project aims to develop a technology, based on deep learning neural networks, exploiting the power of Artificial Intelligence, for the improvement of mammographic cancer prevention. Today 93% of the screening mammograms carried out are negative, a comforting figure, but highly time consuming for the professional resources involved. The goal of Health Triage technology is to overturn the current paradigm, improving its efficiency. The screening mammograms acquired are processed by AI Triage technology, those identified as negative, with 100% absolute certainty, are reprogrammed at the next control exam. This optimizes the work of radiologists so that they can devote their precious time to women who need a more careful reading.

Every year, all women aged 45 to 74 living in Europe are invited and undergo a screening mammography exam. Unfortunately, there is a professional deficit. In several European territories and in some Italian regions there is a lack of doctors to carry out this activity with the right attention and in the necessary dimensions. Health Triage technology can help solve this problem by enabling the achievement of optimal coverage goals set by screening program guidelines. AI Triage technology can offer an adequate response to the growing demand for clinical and diagnostic quality by the population, allowing a wide spread of these prevention initiatives in favor of women, essential for saving lives.

WHAT ARE THE GOALS OF AI TRIAGE?

  • Identification of definitely negative mammograms in the screening process (currently negative mammograms are 93% of the exams)
  • Significant reduction of mammograms to be reported
  • Improvement of the efficiency of the radiologist up to 143%
  • Increased precision in clinical diagnosis by eliminating doubtful cases or errors due to fatigue as much as possible
  • Cost reduction for subsequent diagnostic investigations for public or private health facilities

SPREAD OF THE DISEASE WORLDWIDE

  • It is the most common cancer in the female population in Western countries
  • It is the leading cause of cancer death in women in Italy (Source: Airc)
  • 2 million new cases are identified every year worldwide
  • In Europe, 1 in 10 women are at risk of developing breast cancer
  • This mortality can be reduced when the disease is diagnosed early before symptoms occur

Throughout Europe there are free screening programs, organized by invitation and supported by awareness campaigns. All screening programs offer the female population, as recommended by the WHO (World Health Organization), a 2D mammography exam. The organizational and logistical commitment is enormous. Just think that in Italy alone two million mammograms are performed per year. The main screening is based on 2D mammography, but a new technique called Tomosynthesis or 3D mammography has also been developing for some years. The invitation to screening programs is stratified according to the age group and takes place via personalized letters and/or by telephone. A level of standardization that has simplified the process of involving the population in prevention programs, but does not adequately take into account the peculiarities of each individual case. In this sense, there is a need to develop personalized screening, based on the clinical and historical characteristics of the patients.