Mexico license | Médica Los Ángeles

Portable iBreastExam for Mexico

A fast, painless, radiation-free exam that helps healthcare professionals identify breast lumps within minutes and guide medical follow-up.

  • Portable
  • Painless
  • Radiation-free
  • Results in minutes
Portable iBreastExam device
Evaluation in minutesA trained professional performs the exam and creates a tactile map to support clinical evaluation.

Differentiators

Designed to expand access

Portable, fast, and easy to integrate into medical offices, clinics, and health programs.

Portable

Bring the exam to a medical office, clinic, or community health program.

Painless

The evaluation is performed on the skin without pain for the patient.

Radiation-free

Measures tissue changes without ionizing radiation.

Fast

Creates a tactile map and documentation within minutes.

Accessible

Helps bring initial evaluation closer to more women.

Early detection

Earlier detection changes the pathway

Finding an abnormality early allows medical evaluation and follow-up to begin sooner. iBreastExam helps bring that first step closer to more women.

View reference
98%survival

Stage 1

Cancer only affects the breast.

16%survival

Stage 4

Cancer has spread to other parts of the body.

In Latin America, about 50% of breast cancer cases are diagnosed at the metastatic stage.
iBreastExam device beside a screen with findings report

An accessible first step

A trained professional performs iBreastExam within minutes, without pain or radiation. If the exam identifies an area of concern, the patient continues through the appropriate medical pathway.

How it works

How it works

During the exam, capacitive sensors measure tissue stiffness differences and create a tactile map that supports clinical evaluation.

  1. 01

    Prepare

    A trained professional registers the patient and calibrates the device.

  2. 02

    Scan

    The professional moves the device across the breast without pain or radiation.

  3. 03

    Document

    The system creates a pressure map and report that support clinical evaluation.

Healthcare professional using iBreastExam during an examination
A trained healthcare professional performs the exam on the skin and guides the patient through the process.

Technical profile

iBreastExam Gen II

Institutional summary based on FDA 510(k) K190575. Confirm the exact Mexico unit model before final commercial materials.

Open FDA K190575
ClassificationBreast Lesion Documentation System
FDA class / codeClass II · NKA
Intended userTrained professional

System

Device
Gen II scanhead
Software
iBEConnect
Includes
Computer system, USB charger and cables

Sensing

Sensors
648 capacitive
Area
40 x 35 mm
Lesion
5 mm or greater

Operation

Connection
Bluetooth
Setup
Calibration before each use
Modes
Guided normal and quick scan

Report

Output
Color tactile / pressure map
Management
Display, store, retrieve, print and generate reports

Contact

Material
ABS
Patient
Skin, 5-10 minutes
Cleaning
Medical 70% isopropyl alcohol

Setting

Use
Physician office, hospital or primary care
Sterility
Non-sterile

This profile describes Gen II under FDA K190575; it does not communicate diagnosis or replace clinical studies.

Implementation

Bring iBreastExam to your institution

Médica Los Ángeles supports demonstrations, protocols, and program design for clinics and institutions in Mexico.

Define the program

Align the population, sites, clinical leads, and follow-up pathway.

See the equipment

Review the mechanism, documentation, and required training.

Launch a pilot

Test the workflow with scheduling, staff, patients, and institutional follow-up.

Médica Los Ángeles is the authorized commercial channel for iBreastExam in Mexico.

Frequently asked questions

What is iBreastExam?

iBreastExam is a portable device that helps healthcare professionals identify breast lumps and document tissue stiffness differences. The exam takes a few minutes, causes no pain, and uses no radiation.

Does iBreastExam replace mammography or ultrasound?

iBreastExam works as a support tool within a clinical evaluation. It does not replace mammography, ultrasound, biopsy, or other studies a healthcare professional may recommend.

Who can perform the exam?

A trained healthcare professional performs the exam in a medical office, clinic, hospital, or institutional program with an established follow-up pathway.

Does it hurt or use radiation?

The exam is performed on the skin, causes no pain, and uses no ionizing radiation. A trained professional guides the patient through the evaluation.

How long does the examination take?

The scan is completed within a few minutes. Total time may include registration, preparation, explanation, and the steps defined by each institution.

What information does the device produce?

iBreastExam Gen II creates a surface pressure map to document palpable lesions during a clinical breast exam. The professional interprets that information alongside the patient's evaluation.

What happens if there is a finding?

The result should lead to professional medical assessment. Depending on clinical judgment, the patient may need additional examination, diagnostic imaging, follow-up, or specialist referral.

Which institutions can use it?

It may be considered by clinics, medical offices, community screening days, corporate health programs, detection campaigns, and institutional networks that want to bring initial evaluation closer to more women with a clear follow-up pathway.

Can it be used at home?

No. iBreastExam is intended for use by trained professionals within a clinical evaluation.

Who commercializes iBreastExam in Mexico?

Médica Los Ángeles holds the license to commercialize iBreastExam in Mexico. The product and technology belong to UE LifeSciences; local commercial operation for the country is handled by Médica Los Ángeles.

Clinical evidence

Evidence and validation

Global experience and clinical validation make it possible to evaluate iBreastExam with verifiable data and clear limits of use.

2M+exams enabled globally
12countries reported by iBreastExam
25,000+women in clinical validation

Global iBreastExam

Global use and validation

Reports FDA clearance, 2M+ exams enabled in 12 countries, and clinical validation in 25,000+ women.

UE LifeSciences

Technology and mechanism

Describes the device as portable, fast, painless, and radiation-free; explains capacitive sensors used to measure elasticity.

FDA 510(k) K190575

Indicated use and limits

Indicates professional use to document palpable lesions during clinical breast exam; not for home use or diagnosis.

Clinical literature

Evaluation and validation

Includes references such as The Lancet Global Health 2022 and WJSO 2016 on community evaluation and low-resource validation.

Contact

Discover iBreastExam for your institution

Request information, a demonstration, or an implementation proposal for Mexico.

Direct contact: concacto@medicalosangeles.mx. WhatsApp, phone, address, and legal notice are pending approval.