Healthcare Economics & Policy

The Medical Imaging and Technology Alliance (MITA) applauded 12 U.S. governors for writing a letter strongly encouraging Senate Majority Leader Mitch McConnell, R-Kentucky, and Speaker Paul Ryan, R-Wisconsin, to permanently repeal the medical device tax before the end of the year.

General Electric (GE) has filed the paperwork for an initial public offering (IPO) for its healthcare unit, GE Healthcare, according to numerous sources familiar with the ongoing situation. The offering is expected to take place by the middle of 2019.

The final guidance outlines program policies, features and the process for manufacturers when pursuing the breakthrough designation, according to a recent FDA news release.

When finalized, the draft will supersede the guidance first issued on the subject in 1989 by the FDA, entitled the “Clarification of Radiation Control Regulations for Diagnostic X-ray Equipment."

The Washington University School of Medicine in St. Louis (WUSTL) was awarded a five-year, $6.3 million grant to establish a new research center to develop and test novel PET tracers.

The Right Scan Right Time patient and survivor community network of the Medical Imaging and Technology Alliance (MITA) met with Senators at Capitol Hill last week urging for permanent repeal of the medical device tax, according to a recent MITA news release.

Radiology has the highest use of telemedicine for patient interactions than any other medical specialty, according to results from a nationally representative survey published in the December issue of Health Affairs by the American Medical Association (AMA).

If finalized, the proposed regulations and requirements of the new rule will “provide structure, clarity and transparency” for the De Novo classification process and include processes and criteria for accepting, granting, declining and withdrawing De Novo requests, according to the FDA.

Valerie P. Jackson, MD, was named president of the Radiological Society of North America (RSNA) Board of Directors, Wednesday, Nov. 28, at its annual meeting in Chicago.

The Radiological Society of North America (RSNA) elected Jeffrey S. Klein, MD, to its board of directors at its annual meeting in Chicago. Klein will serve as the board liaison for publications and communications.

The FDA has announced plans to modernize and finalize its 510(k) clearance pathway as part of a continuing effort to advance the review of safety and effectiveness of medical devices, according to a recent statement from FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health (CDRH).

The NFL, on Thursday, Nov. 15, awarded more than $35 million in grants for research focused on the diagnosis and treatment of concussion-related brain injuries, according to the league. The grants are part of its 2016 commitment to enhance player safety.