Hologic’s 3Dimensions™ System for 3D Mammography Receives EUREF Type Test Certification

Rhea-AI Summary

Hologic, Inc. (Nasdaq: HOLX) has announced that its 3Dimensions™ mammography system received EUREF Type Test certification, making it the first digital breast tomosynthesis system to achieve this distinction. This certification verifies that the system meets stringent European standards for image quality and radiation exposure. The 3Dimensions system provides enhanced patient comfort, improved workflow for radiologists, and is recognized for its high resolution and speed. This achievement highlights Hologic's commitment to advancing women's health through innovative technology.

Positive

• First digital breast tomosynthesis system to receive EUREF Type Test certification.
• Certification assures compliance with high European standards for image quality and radiation exposure.
• Improvements in patient comfort and workflow efficiency for radiologists.
• Recognition boosts brand credibility and aligns with Hologic's mission in women's health.

Negative

• None.

3Dimensions System Earns Distinction for Meeting or Exceeding Rigorous European Image Quality and Dose Standards

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, announced today that its 3Dimensions™ mammography system was awarded EUREF Type Test certification by the European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services (www.EUREF.org).¹ It is the first digital breast tomosynthesis (DBT) system to receive such a distinction, and one of only nine mammography systems overall to earn certification.

The mission of the nonprofit EUREF organisation is to raise standards by bringing together the best examples of quality control in mammography screening from regional and national breast cancer programs across Europe. The type test certification assures hospitals and imaging centers that the 3Dimensions 2D and 3D systems have each passed a rigorous series of mechanical and clinical tests demonstrating that the system meets the image quality, radiation exposure and stability standards set by EUREF for screening and diagnostic mammography equipment. Both mammography systems were tested at two clinical sites in the Netherlands for screening and diagnostic uses.

“The work being done by EUREF contributes greatly to ensuring women receive quality screenings and care across Europe. We are honored to be the first DBT system to meet their rigorous standards,” said Tanja Brycker, Vice President, Strategic Development, Breast & Skeletal Health and Gynaecological Surgical Solutions at Hologic. “EUREF certification is not easy to come by. We are proud that our 3Dimensions system has joined two of our other mammography systems in being recognized. These certifications reflect our commitment to developing high-quality medical technology that improves women’s health.”

The 3Dimensions system features breakthrough improvements designed to transform the patient experience without compromising on speed, dose or accuracy. The system is the fastest, highest resolution breast tomosynthesis system available,² and is clinically proven to be more comfortable³ for patients while providing an enhanced workflow for radiologists. In addition to this certification, EUREF has previously certified the company’s Selenia® digital mammography and Selenia Dimensions® 2D systems.

About Hologic, Inc.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.Hologic.com.

Hologic, 3Dimensions, Dimensions and Selenia are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.

Forward-Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.

This information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to womenshealth@hologic.com.

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¹ EUREF. Results EUREF Type test. https://www.euref.org/type-test-equipment/euref-type-test-results. Last accessed 15 September 2022
² Data on file and from public sources, 2017
³ Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00119 Rev 003 (2017)

Source: Hologic, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221103005150/en/

Media Contact:

Jane Mazur

Vice President, Corporate Communications

+1.508.263.8764

jane.mazur@hologic.com



Investor Contact

Ryan Simon

Vice President, Investor Relations

+1.858.410.8514

ryan.simon@hologic.com

Source: Hologic, Inc.

FAQ

What is the significance of Hologic's 3Dimensions mammography system receiving EUREF Type Test certification?

The certification signifies that the 3Dimensions system meets rigorous European standards for image quality and radiation exposure, enhancing its credibility in the market.

When was the EUREF Type Test certification awarded to Hologic's 3Dimensions system?

Hologic announced the certification on November 3, 2022.

What are the key features of the 3Dimensions mammography system?

The 3Dimensions system is recognized for its high resolution, speed, and improved patient comfort, providing an enhanced workflow for radiologists.

How many mammography systems have received EUREF Type Test certification?

Only nine mammography systems overall have received EUREF Type Test certification, with Hologic's 3Dimensions being the first digital breast tomosynthesis system.

How does EUREF certification impact hospitals and imaging centers using Hologic's technology?

The certification assures hospitals and imaging centers that the 3Dimensions system meets high-quality standards, ensuring better patient care and diagnostic accuracy.