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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.

HealthMyne Appoints National Oncology Leader to Board of Directors

HealthMyne, a pioneer in applied radiomics, has announced the appointment of Mimi Huizinga, MD, MPH, FACP, to its board of directors.

MITA Applauds CMS for Creation of Medicare Coverage Pathway for Innovative Medical Technologies

The Medical Imaging & Technology Alliance (MITA), the leading organization and collective voice of medical imaging equipment, radiopharmaceutical, contrast media, and focused ultrasound device manufacturers, today applauded the Centers for Medicare & Medicaid Services (CMS) for its recently issued final rule concerning the Medicare Coverage of Innovative Technology (MCIT) program.

KA Imaging Appoints Seasoned Industry Executives to Key Leadership Positions

Manufacturer KA Imaging has appointed Shawn Campbell as vice president of operations and Robert Moccia as vice president of sales, USA and Canada.

FDA Issues a Draft Guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.

Facts About the Guidance
The MR environment presents unique safety hazards for patients and other persons with medical devices near or inside an MR system. This draft guidance, when finalized, is intended to:

  • Provide recommendations on testing for assessing the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment.
  • Identify test methods that address specific hazards and provide recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling.

Submit Comments on the Draft Guidance
This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2019-D-2837.

Questions?
If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.

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