Healthcare Economics & Policy

This exemption of certain unclassified medical devices from 510(k) requirements aims to achieve two goals: decrease regulatory burdens on the medical device industry and reduce costs required to comply with federal regulations, while allowing patients continued access to medical devices.

A contract dispute between Chattanooga, Tennessee-based Erlanger Health System and Tennessee Interventional and Imaging Associates (TIAA) is threatening to upend the hospital’s premiere stroke program, according to documents obtained by the Times Free Press.

In 2018, capital investments in startup companies developing medical imaging AI solutions reached almost $580 million—more than double the 2017 amount of $270 million, according to a new market report published Jan. 31 by Signify Research.

“Applying the least burdensome approach means gathering the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time,” according to the agency. 

The Liberal National Government of Australia announced it is providing $375 million for 50 new MRI licenses at Medicare-eligible locations across the country, according to a recent release from the office of Greg Hunt, Australia’s Minister for Health.

General Electric (GE) has changed its original strategy and will now aim to sell nearly half of its healthcare unit, GE Healthcare, according to GE CEO Larry Culp.

The world market for digital pathology is expected to rise to $600 million by 2022, according to a new report from Signify Research. But it will have to overcome some strong obstacles first.

The state-run website—HealthCost—reduced medical imaging costs by five percent for patients and four percent for insurers, according to Zach Brown, PhD, an assistant professor of economics at the University of Michigan in Ann Arbor.

“We believe that people should be able to play a more active role in managing their well-being,” Apple COO, Jeff Williams, said in a prepared statement. “As we learn over time, the goal is to make more customized recommendations that will help members accomplish their goals and live healthier lives.”

The Protecting Access to Medicare Act (PAMA) mandating the use of a clinical decision support (CDS) system when ordering advanced imaging tests could affect up to six million emergency department visits annually, according to estimates published in a Jan. 29 Radiology study. The law is set to go into effect in January 2020.

In 2018, the FDA approved a total of 106 new medical devices including medical imaging technologies—surpassing their record in 2017 of 99 novel device approvals, according to a recent statement from FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the Center for Devices and Radiological Health.

Jeffrey S. Klein, MD, will be stepping down as editor of the Radiological Society of North America (RSNA)’s journal RadioGraphics. In the wake of the announcement, the journal is now looking for a new editor.