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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

Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive

Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.

Policy Approvals

FDA ‘Stands Ready’ To Fight Coronavirus Via Emergency-Use Test Kits While WHO Mulls Virus Spread, Gets Out Guidance

The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.

Policy Approvals

US Senate Approves US-Mexico-Canada Agreement Championed By Industry

The US Senate overwhelmingly approved a bill on 16 January to implement the US-Mexico-Canada agreement, which includes a new chapter on the handling of medical devices supported by the medtech industry.

Policy Trade

US Research Agency AHRQ Puts Out Call For Non-Pharma-Based Pain-Control Device Studies

The Agency for Healthcare Research and Quality (AHRQ) is conducting a review on treatments for acute pain and is asking device manufacturers and other organizations to supply it with studies on nonpharmacological therapies to control pain, including transcutaneous electrical nerve stimulation, ultrasound, heat- and cold-producing devices, and acupuncture.

Policy Comparative Effectiveness

Former Palliative-Care Firm CEO Brad Smith Appointed Head Of CMS Innovation Center

Brad Smith, the former CEO of Aspire Health, a home-based palliative-care company, was appointed director of the Center for Medicare and Medicaid Innovation (CMMI) at the US Medicare agency CMS.

Policy Appointments

Device Week, 10 January 2020 – A Look At US Legislation That Could Touch Medtech In 2020

On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporters Danny Al-Faruque and Sue Darcey about specific pieces of legislation that are expected to pass through the US Congress in the new year and how they’ll impact the medical device sector.

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