Canon Medical’s AI-Powered, Premium Large Bore CT Receives FDA Clearance

Canon Medical Systems USA, Inc. has received FDA clearance for the Aquilion Exceed LB CT system, giving clinicians the opportunity to see more during radiation therapy planning for accuracy, precision and speed.

FDA Clears MULTIX Impact C Ceiling-Mounted DR System

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the MULTIX Impact C ceiling-mounted digital radiography (DR) system as well as the MULTIX Impact VA20, a new version of the established floor-mounted parent DR system.

FDA Approves Seno Medical’s Breast Cancer Diagnostic Technology

The Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments Inc.

Philips to Acquire Capsule Technologies Inc.

Royal Philips has signed an agreement to acquire Capsule Technologies Inc., a provider of medical device integration and data technologies for hospitals and healthcare organizations.

MXR Imaging Adds Ultrasound to Platinum Certified Program

MXR Imaging Adds Ultrasound to Platinum Certified Program

MXR Imaging Inc. has announced the next offering under its Platinum Certified Pre-Owned brand of products, Platinum Certified Ultrasound. Under the Platinum program, all products undergo a documented process that includes the extensive testing and replacement of parts and components of pre-owned diagnostic medical products.

For years, MXR Imaging has been successfully selling GE, Philips, Siemens and Sonosite systems as certified pre-owned ultrasound, both portable and cart-based units. Under the recently launched Platinum Certified brand, these ultrasound systems will now adhere to standards set by MXR’s ISO 13485:2016 certified quality management system and includes parts and labor warranty.

Key requirements for certifying pre-owned ultrasound units under the program include a multi-point refurbishment checklist to bring the equipment to “as new” status, including:

  • Cosmetic: Sanding, repainting of any worn external covers to bring the external unit back to “as new” condition with complete decontamination
  • Mechanical: Replacement of keyboards, buttons and knobs
  • Components/Electronics: Replacement of worn internal components including computer boards
  • Quality Assurance: Full inspection, evaluation of systems and sub-systems to identify and replace high-failure parts

“Many of our customers enjoy the economic advantages of owning an MXR Platinum Certified Ultrasound for two reasons,” stated Lynn Kaplan, vice president – ultrasound division & QA/RA, “1) they lowered their cost of ownership without risk to the patient or dependability of the technology or 2) they were able to upgrade their imaging capabilities by choosing a pre-owned model with more functionality and features than their budget would have allowed if they had chosen a new system.”

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