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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

DTC Ads For Genetic Tests Increased 18-Fold Over 20 Years, Study Says

The number of direct-to-consumer advertisements for molecular-based tests rose exponentially from 1997 to 2016, according to a medical marketing analysis released earlier this month in the Journal of the American Medical Association. Simultaneously, laboratory test manufacturers increased spending on ads and direct spending on physicians who work with the tests from $75.4m to $82.6m.

In Vitro Diagnostics Advertising, Marketing & Sales

Expect FDA Diagnostics-Reform Bill Passage In 2019, Rep. DeGette Says

Passage of a US FDA diagnostics reform bill is one priority for the US House Energy and Commerce Committee in 2019, said cosponsor and committee member Rep. Diana Degette, D-Colo.

Legislation In Vitro Diagnostics

Democratic Leaders Question CMS Charges For ACA Outreach-Targeted User Fees

Chairs of Democratic-controlled health committees in the US House, and Democrats serving as ranking members of US Senate health panels, sent a letter to the Centers for Medicare and Medicaid Services and the Department of Health and Human Services last week questioning the agencies’ expenditures of user-fee funds intended to support outreach activities under the Affordable Care Act, which the Trump administration opposes.

Legislation Reimbursement

New Finance Chair Grassley Will Push Device Tax Repeal, Try To Lower Health-Care Costs

In setting his agenda for the US Senate Finance Committee in 2019, incoming Chairman Chuck Grassley, R-Iowa, says he will continue to cosponsor bills to end the device tax, focus on lowering prescription drugs and other medical product health-care costs, expand tax breaks for business, and make sure Congress has a strong hand in negotiating trade and tariff talks.

Legislation Regulation

Manufacturers Support Health Canada Device Safety Plan, But Clinics May Adjust More Slowly

Device companies in Canada and foreign firms selling to the market likely will be able to adjust to Health Canada’s stepped-up device safety “action plan,” but small health-care facilities and some clinics may face challenges in adjusting to new reporting rules, says the agency and Canadian device industry group MEDEC.

Safety Regulation

US House Speaker Pelosi Prioritizes Ending FDA Shutdown, Lowering Health Costs

Newly-elected Speaker of the House Nancy Pelosi, D-Calif., says her priorities are ending the government shutdown, lowering health-care costs, and adoption of new House rules that could make repealing measures like the medical device tax more difficult.

Leadership Legislation
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