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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.

The FDA issues Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan

FDA

Today, the U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence.

The Action Plan is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device” and outlines five actions the FDA intends to take, which include:

  • Further developing the proposed regulatory framework, including issuing draft guidance on a predetermined change control plan;
  • Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms;
  • Fostering a patient-centered approach, including device transparency to users;
  • Developing methods to evaluate and improve machine learning algorithms; and
  • Advancing real-world performance monitoring pilots.

AI/ML-based SaMD is a rapidly progressing field and the FDA anticipates this action plan will continue to evolve. The FDA welcomes continued feedback in this area and looks forward to engaging with stakeholders on these efforts. We will also continue to collaborate across the FDA to build a coordinated approach in areas of common focus related to AI/ML.

READ THE ACTION PLAN »

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