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Sue Darcey

Senior Reporter

Washington, D.C.
Sue Darcey is a senior reporter covering the medical device and diagnostics industry. Her current fields of expertise and interest include monitoring medical device post market performance and safety, development of new genomic and laboratory developed tests, the influence of industry lobbying and campaign contributions over Senators’ and Representatives’ voting practices and lawmaking on devices, and FDA approvals of diagnostics for emerging diseases, including tests for Ebola and Zika viruses. A Washington, D.C.-based trade journalist with over 30 years’ experience covering Capitol Hill and regulatory agencies including FDA, CMS and the Environmental Protection Agency, Sue is constantly on the look-out for any problems or safety issues connected to device use, ways that firms resolve those issues, and any new regulations that arise from the challenges. 
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Power Morcellator Use Increases Cancer Risk, FDA Verifies

There is a 1-in-225 to 1-in-580 risk that women getting fibroid removal surgery through hysterectomies or myomectomies may have hidden uterine sarcomas, US FDA said Dec. 14, and verified that power morcellation use during the surgeries will result in higher rates of cancer recurrence.

Gynecology & Urology Regulation

FDA Authorizes Emergency Use Of Devices In War Time, Bill Signed By The President Clarifies

President Trump signed off on legislation allowing US FDA to authorize additional emergency uses for medical products to reduce deaths and impacts of injuries caused by "agents of war." The signature ends a turf battle between FDA and the Department of Defense over authorizing products needed quickly under the emergency conditions of war.

Policy Legislation

US FDA Panel Votes 'No' On Barricade Implant To Stop Reherniation

A US FDA Orthopedics Advisory Panel voted 8-5 that the benefits do not outweigh the risks of implanting Intrinsic Therapeutics Inc.' Barricade prosthesis based on safety concerns, in particular a tendency for the device to break and separate into the lumbar column post implantation. Also, some panel members were not convinced that the device would improve patient function or allow people to return to their jobs.

Advisory Committees Regulation

New Path For 510(k)s On US FDA's FY 2018 Guidance-Priority Plan

FDA intends to draft a guidance by March outlining a voluntary, alternative 510(k) pathway for sponsors to demonstrate the substantial equivalence of some products by relying more on objective performance criteria.

Regulation United States

US Congress Passes Short-Term Funding, While Debt Ceiling Lingers

Congress managed to temporarily stave off a government shutdown, but a continuing resolution bill passed Dec. 7 gives lawmakers only two more weeks – until Dec. 22 – to come up with a final budget plan for 2018. Meanwhile, a deal to raise the debt ceiling, allowing more spending next year, still needs to be set.

Legislation United States

Medtech-Supporter Sen. Al Franken To Resign, After Harassment Charges

Sen. Al Franken, D-Minn., who has championed key device regulatory reform changes favoring the medtech industry that are now law, will step down from his post, following newly revealed charges of sexual harassment by a former congressional staffer in 2006.

Policy & Regulation Leadership
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