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Tag: MITA

Focusing on Regulatory Environment

Focusing on Regulatory Environment

This piece was originally published in the November 2016 issue of electroindustry. Diane Wurzburger, Executive, Regulatory Affairs, GE Healthcare MITA’s Technical and Regulatory Committee (TRC) promotes a regulatory environment that supports growth and innovation in medical imaging. In 2016, the TRC set three priorities: successful Medical Device User Fee Amendments (MDUFA) negotiations; critical to quality (CtQ) engagement, which is part of a of the U.S. Food and Drug Administration Read more […]

Medical Device Tax Repeal: Good for Patients and Good for the Economy

Medical Device Tax Repeal: Good for Patients and Good for the Economy

This piece was originally published in the November 2016 issue of electroindustry. Andy Dhokai, MPPA, Director, Federal Relations, MITA As congressional action ceased as a prelude to national and local elections, MITA continued to make the case for full repeal of the 2.3 percent excise tax on the sale of medical devices enacted as part of the Affordable Care Act. We are using the first year of a two-year suspension of the tax, passed in December 2015, to show members of…

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Standardizing the Value of Quality

Standardizing the Value of Quality

This piece was originally published in the November 2016 issue of electroindustry. Jim Nestel, Manager Service Projects and Installations, Hitachi Medical Systems Only original equipment manufacturer (OEM) service providers are required by the Food and Drug Administration (FDA) to have a quality management system (QMS) to assess medical imaging equipment. Although many non-OEM medical imaging device service providers perform excellent work, the lack of such a requirement leaves the Read more […]

Working Together in Medical Imaging

Working Together in Medical Imaging

This piece was originally published in the November 2016 issue of electroindustry. Nelson Mendes, CEO, Ziehm Imaging and Chair, MITA Board of Directors As chair of the MITA Board of Directors, I am pleased to reflect on the ways MITA benefits the medical imaging industry, to highlight the work we’ve done in 2016, and to bring attention to the important role membership plays in our interactions with patients, providers, payers, and regulators. MITA’s member companies and staff set Read more […]

Repeal the Medical Device Tax

Repeal the Medical Device Tax

Encourage Medical Innovation, Save Lives, and Fuel the U.S. Economy This piece was originally published in the November 2016 issue of electroindustry. Congressman Erik Paulsen (R-MN) Investing in medical innovation is essential to ensuring the health and prosperity of our nation and affords the opportunity to export American ingenuity. Unfortunately, manufacturers’ ability to make such investments was threatened by a provision of the Affordable Care Act (ACA) that placed a 2.3 percent Read more […]

The MRI That Saved My Life

The MRI That Saved My Life

This piece was originally published in the November 2016 issue of electroindustry. Josh Perry, Pro BMX Rider It is said—mostly to scare young riders into taking appropriate safety precautions—that the likelihood that a motorcycle rider will have an accident is 100 percent. In my career as a professional bicycle motocross (BMX) bike rider, I can tell you that not only is there a 100 percent chance you will fall sometimes, but there is almost a 100 percent chance that you will…

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Big Data Breeds New Profession

Big Data Breeds New Profession

This piece was originally published in the August 2016 issue of electroindustry. Cheryl Kreider Carey, CAE, Director of Operations and Administration, MITA What do you want to be when you grow up? We’ve probably all asked this question many times. But how many times have you heard “data scientist” in reply? The current data-driven revolution is leaving much in its wake. Laws and regulations are necessarily adapting while new professions are emerging, all in response to the seismic Read more […]

Advancing Medical Imaging

Advancing Medical Imaging

This piece was originally published in the August 2016 issue of electroindustry. Cheryl Kreider Carey, Director, Operations and Administration, MITA What’s the big idea? At the Medical Imaging & Technology Alliance (MITA), improving business for 55 members in the medical imaging ecosystem is big. As one of MITA’s 10 staff members, I am fortunate to work alongside MITA’s members on the technical front and run MITA’s internal operations. Precipitated by this age of digital Read more […]

Regulatory Challenges Emerge for Additive Manufacturing

Regulatory Challenges Emerge for Additive Manufacturing

This piece was originally published in the August 2016 issue of electroindustry. Megan A. Hayes, Director, Regulatory and Standards Strategy, MITA Additive manufacturing (AM) is another term for the synthesis of three-dimensional objects—otherwise known as 3D printing. This concept is nothing new to the U.S. Food and Drug Administration (FDA), which already has approved or cleared more than 80 medical devices and one prescription drug that are manufactured using 3D printing processes. On Read more […]

MITA Smart Dose Standard Enhances Patient Care

MITA Smart Dose Standard Enhances Patient Care

This piece was originally published in the August 2016 issue of electroindustry. Megan A. Hayes, Director, Regulatory and Standards Strategy, MITA The Medical Imaging and Technology Alliance (MITA), a division of NEMA, published NEMA XR 31-2016 Standard Attributes on X-ray Equipment for Interventional Procedures in May 2016. This new standard, which pertains to MITA Smart Dose Interventional technology, offers healthcare providers a reference  for identifying key features that contribute Read more […]