MITA Calls for Strengthened Enforcement of Medical Device Remanufacturing

The Medical Imaging & Technology Alliance (MITA) has written a letter that calls for the U.S. Food and Drug Administration’s (FDA) to strengthen its guidance on medical device remanufacturing and urged the agency to take the necessary steps to properly enforce the...

Perlin Named President of The Joint Commission

The Board of Commissioners of The Joint Commission have announced the appointment of Dr. Jonathan B. Perlin to lead The Joint Commission as its next President and CEO. The appointment is effective March 1, 2022. Widely known for his leadership in healthcare quality...

GE Healthcare Introduces New CT System

GE Healthcare has unveiled Revolution Ascend[i] with Effortless Workflow, offering clinicians a collection of artificial intelligence technologies that automate and simplify time-consuming tasks to increase operational efficiency and free up time for clinicians to...

United Imaging uCT ATLAS Earns FDA Clearance

United Imaging has announced FDA clearance for the uCT ATLAS, the latest in the company’s computed tomography (CT) portfolio of scanners and the 25th FDA clearance for the company overall.

KA Imaging’s Reveal 35C Included in WHO Compendium

KA Imaging’s Reveal 35C has been included in the World Health Organization’s (WHO) compendium of innovative health technologies for low-resource settings, launched August 31, 2021.

This compilation features emerging technologies assessed and found to potentially improve health outcomes, the quality of life, or offer a solution to unmet medical needs. The WHO performs technical, health technology, regulatory system, quality system, management, and safe use assessments.

The information provided is manufacturer-reported and meant to inform professionals in the medical field about the advantages and challenges involved with implementing innovative health technologies in low-resource settings.

This fifth edition of the compendium prioritizes the need for COVID-19 response and other current health issues.

Reveal 35C is the world’s first portable dual-energy X-ray detector. It has both USA FDA 510(k) clearance and a Health Canada Medical Device Licence. It is currently being used at two clinical sites in Canada, with promising early results. The application for use screening COVID-19 pneumonia is of particular significance now.

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