Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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. 
Set Alert for Articles By Sue Darcey

Latest From Sue Darcey

Performance Issues With CDC’s COVID-19 Assay Reagent Slows Rollout Of Test Kits To US States

A reagent in a batch of COVID-19 tests shipped by the US Centers for Disease Control and Prevention to state laboratories “wasn’t performing consistently,” a top CDC official says, so the agency is reformulating it – slowing down the labs’ ability to use the diagnostic, which yielded inconsistent results when quality-tested. But waiting in the wings are commercial coronavirus test kits being developed by Qiagen and Cepheid; both firms say they’ll submit the kits to the FDA for emergency-use approval.

Regulation FDA

Study Says FDA Waited Too Long To Ban Pelvic Mesh For POP Repairs

Roughly 18.5% of patients who received reinterventions to fix mesh implants for pelvic organ prolapse (POP) repair experienced complications they will likely endure for the rest of their lives, and they also face a 2.5% higher rate of further surgeries than non-mesh patients, says a recent 54,194-woman study detailed in Obstetrics & Gynecology. The study authors lay out a case that the US FDA should have forced removal of mesh from the market sooner.

Regulation FDA

FDA’s Device Center Could Raid $2.8M From Staff Outreach, Training Kitty In 2021 To Fund Other CDRH Needs

While the Trump administration’s proposed fiscal year 2021 budget for the US FDA would give the agency’s device center a 5.3% increase for medtech product approvals and safety, the center’s lofty plans to become the world’s premier regulator of new AI-driven gadgets, next-gen diagnostics and other novel devices means it will have to tap about $2.8m dollars usually set aside for staff training and outreach to help meet its ambitious goals.

Regulation FDA

Novacyt, Co-Diagnostics, Other Test Firms Seek Fast-Track EUA Approval From FDA For Coronavirus Dx's

Diagnostics companies around the world – including Novacyt, Roche, Co-Diagnostics and Mammoth Biosciences – are developing and launching tests to fight the coronavirus in China and other countries as quickly as possible, and some are seeking Emergency Use Authorization (EUA) approval from the FDA so their assays can be used on US patients.

Regulation FDA

US Insurers, Hospitals, Medtech Industry Say Transparency Rule Touted In President’s Speech Is Anticompetitive

US President Donald Trump in his State of the Union address on 4 February touted his 2019 Price Transparency executive order calling on federal agencies to require private hospitals and insurers to publicly reveal the costs of hundreds of their device-related procedures and lab tests – as well as insurers’ negotiated rates for them – so patients can shop for their own health care. But industry maintains the resulting rules out of the Centers for Medicare and Medicaid Services are “anticompetitive,” and a coalition of hospital groups is suing the Department of Health and Human Services to stop their implementation.

Policy Reimbursement

FDA Responds To Coronavirus By Getting Out First Emergency-Use Novel Coronavirus Diagnostic

The US agency on 4 February issued its first Emergency Use Authorization of a 2019-novel coronavirus test by enabling emergency use of the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The move will allow use of the test at any CDC-qualified lab across the US.

In Vitro Diagnostics FDA
See All
UsernamePublicRestriction

Register