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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

US Senate Recommends Funding For FDA Device Shop In 2020 To Support Cybersecurity, Virtual Trials

The US Senate Appropriations Committee passed FDA funding levels for 2020 on 19 September that would support medical device cybersecurity and medtech manufacturing, but a continuing resolution measure is waiting in the wings to provide the full Senate more time to consider the measure before the new fiscal year starts on 1 October.

Policy FDA

FDA Unveils Technology Modernization Plan To Better Handle ‘Tsunami’ Of Incoming RWE Data

The US agency has introduced a new action plan geared toward handling an expected incoming storm of real world evidence (RWE) data that companies will be submitting to support future device and drug approvals.

FDA Policy

US Senate To Mark Up FDA Funding Bill Next Week

While the US Senate Appropriations subpanel handling FDA funding plans to mark up a 2020 funding bill for the agency on 17 September, disagreement between the Senate and House on agency spending caps could delay the final funding accord between the two chambers, forcing the FDA to run on continuing resolution dollars in early October.

Legislation FDA

Medicare Fraud Rule Calls For Disclosures On Affiliations With Excluded Health Program Providers

Providers and suppliers to Medicare, Medicaid and the Children’s Health Insurance Program (CHIP) are required to disclose any affiliations they've had with individuals who've committed fraud under federal health-care programs under a final rule released on 10 September.

Enforcement Medicaid

House Panel Hearing On ‘Healthy MOMMIES Act’ Supports Telemedicine Use

Obstetricians and maternal health research experts at a 10 September US House hearing on ways to lower maternal mortality rates supported passage of H.R. 2602, which would promote greater use of telemedicine as a means for expectant and new mothers to gain mental-health counseling and health-care advice from providers, among other provisions.

Legislation Medicaid

Rep. Shimkus, Author Of 'Cures' Device Provisions, Joins Exodus Of Republicans Retiring In 2020 From US House

Illinois Rep. John Shimkus, a well-known pro-medtech industry bill sponsor, announced on 30 August his plans for a January 2020 retirement. He joins at least 15 Republican House members who recently said they are also ending their Capitol Hill careers, leaving six vacancies on the US House Energy and Commerce and Ways and Means panels prior to the 2020 elections.

Leadership Legislation
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