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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.

ICE Moves to May

Mark your calendar, the conference dedicated to imaging directors, radiology administrators and imaging engineers is moving to May 11-12 in sunny Ft. Lauderdale Beach, Florida.

oneSOURCE Creates Free Resource Page with Up-to-Date COVID-19 Vaccine Information

Today, oneSOURCE, an RLDatix company and leading healthcare management solution, announced a new COVID-19 vaccine resource page to assist healthcare professionals during the initial administration phases of the vaccine.

FDA Reclassifies Medical Image Analyzers, Including Computer-Assisted Detection (CADe) Devices

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician’s attention to portions of an image that may reveal abnormalities during interpretation of patient radiology images by the clinician. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device type.

This order is effective February 21, 2020.

For more information, click here.

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