LINDA - ED

Digital innovation in the fight against Breast Cancer.

Affordable and mobile health to reach 5 continents.

How we designed the solution

LINDA was created and based on thousands of mammograms, ultrasounds and biopsies. Our medical and engineering team, composed of PhD professionals from the main universities in Brazil, created a powerful neural network that evaluates more than 1.5 million variables to deliver a fast and safe result to medical teams.

Mammograms
Ultrasound
biopsies

Operation principle

Detection for prevention. Identify the possible injury first.

We use thermal contrast to point out a suspected lesion formation.

Base Journey

The image is analyzed by a powerful Artificial Intelligence system to detect suspicious patterns.

The analysis concludes the presence of lesions in the breast that demand immediate investigation by complementary exams.

Image capture

Smart analysis

Professional analysis

Detection

Proper guidance

Through LINDA, an image captured without physical contact with the patient.

With the data collected by LINDA, the physician receives the necessary information to support decision making.

The clinical decision dictates the prioritization of the care of high-risk patients with the support of LINDA, reducing the time of the diagnosis journey.

Image capture

Through LINDA, an image captured without physical contact with the patient.
Smart analysis

The image is analyzed by a powerful Artificial Intelligence system to detect suspicious patterns.
Professional analysis

With the data collected by LINDA, the physician receives the necessary information to support decision making.
Detection

The analysis concludes the presence of lesions in the breast that demand immediate investigation by complementary exams.
Proper guidance

The clinical decision dictates the prioritization of the care of high-risk patients with the support of LINDA, reducing the time of the diagnosis journey.

Technical Validations

LINDA is approved by Anvisa under notification number 82195910001 Risk Class II and is conducting additional clinical studies to expand its indications for use.

Read the clinical study published in British Journal of Cancer Research which compares LINDA versus Mammography in a breast cancer screening setting.

1. GAMP5 - Good Automated Manufacturing Practice - GAMP5, published by ISPE in February 2008;

2. Anvisa Systems Validation Guide, published by ANVISA - in April 2010;

3. Qualifications and Validations: Sindusfarma Guide for the Pharmaceutical Industry – published by Sindusfarma in June 2016;

4. ISO13485/2016 – Medical Devices – Quality Management Systems – Requirements for regulatory purposes – third edition / Medical Devices - Quality Management System, third edition - published on 2016/03/01;

5. RDC No. 16 - Good Manufacturing Practices for Medical Products and in vitro diagnostic products;

6. Normative Instruction - IN No. 47, OF AUGUST 21, 2019 - Provides for Good Manufacturing Practices complementary to qualification and validation activities;

7. ISO IEC 14971 – Healthcare Devices – Application for risk management to healthcare devices - published in December 2019

8. ISO IEC 27001 - Information Technology - Security Techniques - Information Security Management Systems - published in September 2013;

9. FDA 21 CFR Part11 Electronic Records; Electronic Signatures published by the FDA – Food and Drug Administration – in March 1997;

10. ICH Q9 – Quality Risk Management - International Conference On Harmonization Of Technical Requirements For Registration Of Pharmaceuticals For Human Use, published by the European Medicines Agency in September 2015;

11. Annex 4 – WHO Guidelines for Sampling of Pharmaceutical Products and Related Materials, WHO Technical Report Series, No. 929, 2005;

For technical collaborations

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