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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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Latest From Sue Darcey

Physicians Failing To Disclose Supplier, POD Arrangements Fuel Kickback Concerns, Senators Say

US Senate Finance Committee leaders say some physicians may have failed to disclose their physician-ownership interests in entities that offer medical supplies to the physician’s own practice, as required under the Physician Payment Sunshine Act. The legislators on March 19 prodded the Health and Human Services' Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) to take a closer look into these arrangements.

Reimbursement Enforcement

FDA Focusing More On Safety Of Device Biomaterials, Attorney Warns

Device-makers will have to take a more proactive approach to understanding the safety of biomaterials they use for their implanted devices, and how these materials might affect patients during post-market use, industry attorney Michele Buenafe of Morgan Lewis & Bockius LLP told Medtech Insight in a March 18 interview.

Regulation Safety

FDA Will Hold Advisory Panel Meeting In Fall On Metal Implant Reactivity

US FDA Commissioner Scott Gottlieb and device center director Jeffrey Shuren reminded the public on March 15 that materials in devices – including metals in orthopedic products and defibrillators – can cause reactions in some patients. They said the agency needs to do "more work” on patient responses to metal implants and other biomaterials, and announced an FDA advisory panel meeting this fall on reactions to metals.

Regulation Safety

AdvaMed Pins Hopes For Device Tax Repeal On 10 Senate Democrats, But Could Lose House Support

A coalition of 27 Senators – including 10 Democrats led by Amy Klobuchar, D-Minn. – on March 7 co-sponsored a bill to permanently repeal the device tax. AdvaMed says support of additional Democrats on this year’s bill should persuade Senate leaders to bring S. 692 to the floor for a vote, or it could be attached to other, "must pass"’ legislation. But the bill’s approval in the Democratic-controlled House is uncertain. Sixty-five of 283 “yes,” voters – mostly GOP – favoring tax repeal in the last session, are no longer in office.

Legislation United States

HHS Secretary Azar Takes Heat At Budget Hearing

HHS Secretary Alex Azar was pressed on issues tied to the Affordable Care Act and the recently proposed FY 2020 budget at a March 12 congressional hearing.

Legislation Reimbursement

NCI Director And Former Dx Start-Up Founder Sharpless Will Helm FDA

After a week of speculation as to who will succeed US FDA Commissioner Scott Gottlieb when he steps down next month, Health and Human Services Secretary Alex Azar announced during a congressional hearing that National Cancer Institute Director Ned Sharpless will step in as acting commissioner. One note of medtech interest in Sharpless' bio: he was a co-founder of a diagnostics company.

Regulation FDA
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