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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

Payment 'Sunshine' Requirements Would Expand For Industry Under Senate-Passed Opioid Bill

A provision to expand Sunshine Act industry reporting requirements for companies in the Senate-passed “Opioid Crisis Response Act” has caught criticism from the device sector, despite overall industry support for the legislation.

Legislation Regulation

House-Passed Tax Bill Would Support Medtech Innovation, Lobbyists Say

The device industry is praising passage of “The American Innovation Act” by the US House. The bill is intended to promote new business start-ups – including fledgling medtech companies – by allowing certain tax deductions for net-operating losses.

Legislation Policy

FDA Looks To Whittle Down Dx Review Load With Pre-Certs, Third-Party Assists

US FDA Commissioner Scott Gottlieb and the agency’s new diagnostics office chief Tim Stenzel want to use a combination of pre-certification, assistance from third-party reviewers and review exemptions to help quickly clear the tsunami of molecular-based diagnostic tests expected to be submitted to FDA for review in the next several years.

In Vitro Diagnostics Regulation

US House Passes Medicare Local Coverage Bill

Proposed legislation to make local coverage determinations by Medicare contractors more transparent and inclusive of industry input has been advanced by the US House and now goes to the Senate.

Reimbursement Market Access

US Agency Advises Against Use Of Advanced Imaging To Diagnose Kids’ Mild Traumatic Brain Injury

The US Centers for Disease Control and Prevention (CDC) has issued a guidance on diagnosing and treating pediatric mild traumatic brain injury, that advises health care providers to avoid use of computed tomography, MRI, single photo-emission CTs, and skull radiographs in diagnosing kids 18 years and younger.

Diagnostic Imaging Neurology

US House Panel Passes Bill To Bring More Transparency To Local Coverage Determination Process

The House Ways and Means Committee advanced legislation backed by the device industry to improve the transparency and accountability of the process Medicare Administrative Contractors use to make local coverage determinations for new medical technology.

Reimbursement Market Access
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