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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

Congress Agrees To Keep FDA, Other Agencies Running At Current Funding Level Through Mid-December

The US Congress this week agreed to keep the FDA and other government agencies funded at fiscal-year 2019 levels, extending the continuing resolution another four weeks until 20 December.

Policy Financing

Hahn Fields Queries On Electrical Stim Devices, Molybdenum Supplies For Imaging At FDA Confirmation Hearing

MD Anderson Cancer Center chief medical officer Stephen Hahn fielded a number of questions senators asked at his 20 November confirmation hearing to lead the US FDA. Chief among them were inquiries about his government experience level, whether he would expedite a ban on electrical stimulation devices used against the intellectually disabled, and how he would address a shortage of molybdenum-99 used in advanced imaging scans.

Policy Appointments

CMS Hospital Price Transparency Rule To Begin Public Reveal Of Device-Related Procedure Prices, Test Costs In 2021

The US Medicare agency on 15 November released a final cost transparency rule calling on hospitals to detail their standard “shoppable services” charges for X-rays, advanced imaging, laboratory tests and an array of other device-related procedures, beginning on 1 January 2021. Meanwhile, an accompanying proposed rule released by the CMS on the same day would require insurance health plans to provide to participants and beneficiaries the insurers’ negotiated rates for all covered health-care items and services.

Medicare Pricing Strategies

FDA Clears Pentax’s Easier-To-Disinfect Duodenoscope

The US FDA cleared Pentax Medical’s new duodenoscope as the first in the US with a disposable elevator part that reduces the number of parts needed to be disinfected compared to earlier designs.

Approvals Regulation

FDA Advisory Panel Debates Science On Human Adverse Biological Reactions To Metal-Containing Devices

US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in dental amalgam at a 13-14 November agency advisory committee meeting. The get-together was held to determine what additional actions the FDA can take to make sure certain patients are protected from immunological risks of the implants. The panel ultimately backed a transition away from mercury amalgam dental fillings and pushed for more research into risks associated with metal implants.

Safety FDA

Senators Question FDA’s Proposed Progressive Approval Pathway For Devices

US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.

Policy Regulation
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