Regulatory
Meeting Regulatory Requirements with FEA
I recently returned from a workshop on Computer Methods for Cardiovascular Devices sponsored by the Federal Drug Administration, the National Heart, Lung, and Blood Institute, and the National Science Foundation
First HHS healthcare innovation awards focus on telehealth technologies to save money
The first batch of organizations to receive Health Care Innovation awards are looking to use telehealth technologies to save money. Made possible by the Affordable Care Act, the awards support 26 innovative projects nationwide that are selected because they aim to “save money, deliver high-quality medical care, and enhance the healthcare workforce.” Health and Human Services (HHS) Secretary Kathleen Sebelius recently named the preliminary awardees announced and said that the programs are expected to “reduce health spending by $254 million over the next three years.”...
User error vs. use error: More than just semantics
A new report promotes standards affecting a paradigm shift in postmarket use-error reporting....
AdvaMed delivers roadmap; details on getting there still sketchy
AdvaMed’s three-year, four-goal strategic plan is proactive, but lacks certain details. ...
Repealing healthcare reform would make medtech stocks healthy, says analyst
Whether the Supreme Court will repeal healthcare reform likely won’t be known until June. If repealed, medtech stocks will improve, says Michael Matson, senior equity research analyst and executive director for Mizuho Securities in New York....
Device tax must go, says AdvaMed and Battelle
A significant change to the US advanced medical technology industry’s operating environment—such as the soon-to-be-implemented medical device excise tax—could cost tens of thousands of jobs, lower personal incomes, and reduce business opportunities worldwide, according to a study recently released by AdvaMed....
FDA and CMS: A path for parallel approvals for innovative technologies
Parallel FDA and CMS review offers an opportunity to reduce the time it now takes to secure Medicare coverage and payment for innovative new products....
Readers don’t believe user fee agreement is worth the price
MedicalDesign.com readers weigh in with opinions on latest medical device user fee agreement. ...
The ins and outs of ESMS
A white paper on the ins and outs of effective standards management systems (ESMS) is available. ...
Editorial: Positive changes will cost medtech
The adage that nothing in this world worth having comes easy can be said of proposed measures to improve the badly bottlenecked regulatory process found in the tentative agreement on a new "Medical Device User Fee Act." ...
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