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FDA Seeks ‘Remanufacturing’ Feedback from Biomeds

A little more than a month ago, the FDA released the draft guidance “Remanufacturing of Medical Devices” and asked healthcare technology management professionals, original equipment manufacturers, third-party repair organizations and more to submit comments.

United Imaging Goes “All-in” for Nashville

United Imaging makes its debut at HealthTrust University and its in-person debut at AHRA in Nashville over the next two weeks. At both events, the company will focus on several unique aspects of how it solves pervasive pain points in procuring and owning medical imaging equipment.

TechNation Asks Biomeds to Share Right to Repair Issues

TechNation is proud to support and be an advocate for the Right to Repair movement in the healthcare technology management and health care community. A new web form specifically allows biomeds everywhere to report incidents when an original equipment manufacturer...

Delivering precision solutions for a changing world

Change has been the one constant in nuclear medicine from the beginning, with the steady arrival of new radiopharmaceuticals, new technologies and an evolving regulatory environment. Today, as nuclear medicine expands rapidly beyond diagnostics and into novel...

FUJIFILM ASPIRE Cristalle Digital Mammography System

Fujifilm Medical Systems U.S.A. Inc. earlier this year announced that its Digital Breast Tomosynthesis (DBT), as an optional software upgrade for its ASPIRE Cristalle digital mammography system, has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA). Known as AMULET Innovality outside of the United States, Fujifilm’s optional DBT upgrade has been widely available in Europe, Asia and Latin America since May 2013. The ASPIRE Cristalle FFDM system with DBT combines Fujifilm’s state-of-the-art hexagonal close pattern (HCP) detector design, advanced image processing and image acquisition workflow to optimize patient dose while maximizing image quality.

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