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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

Medicare Finalizes NGS Test Coverage For Advanced Cancers, Drops Evidence-Collection Provision

The US Centers for Medicare and Medicaid Services March 16 said it will cover next-generation sequencing diagnostic laboratory tests for advanced cancers, broadening its final determination to cover use in relapsed, refractory and stage III cancers, while dropping "coverage with evidence development" conditions.

Reimbursement Market Access

Geisinger And Medacta Pilot Guarantees Coverage Of Hip Replacements For Life

Geisinger Health has teamed up with Swiss-based device-maker Medacta International in a pilot program guaranteeing lifetime coverage of hip replacement costs for Geisenger patients.

Market Access Reimbursement

No-Device 'Right-To-Try' Bill Fails To Pass House Muster

"Right-to-try" legislation aimed at giving severely ill patients access to drug treatments not yet approved by US FDA failed to win support from the needed super-majority in a Tuesday night vote in the US House. Before the vote, the bill's scope was narrowed by removing medical device provisions, and making it applicable only to those facing death within a matter of months. A Senate version still in play retains the device language.

Legislation Policy

FDA Pathway Options Are Growing For Diagnostics, FDA's Gottlieb Tells Commercial Labs

While lab-developed test (LDTs) remain under a US FDA enforcement discretion policy, the agency is working on several fronts to offer appealing regulatory pathways for advanced diagnostic services, FDA Commissioner Scott Gottlieb told American Clinical Laboratory Association members.

Legislation Regulation

Medtech Tools To Help Address Opioid Crisis Face Reimbursement Challenges

A wide variety of devices that could either serve as pain-relief substitutes for opioids, help manage opioid addictions or tackle distribution issues with the overly prescribed medications are facing reimbursement challenges at the US Centers for Medicare and Medicaid Services.

Reimbursement Market Access

Lab Industry, Cancer Groups Want Expanded Medicare Coverage Of NGS For Advanced Cancers

While device firms that create lab test kits, clinical laboratories and cancer medicine groups supported US Centers for Medicare and Medicaid Services' proposed national coverage determination for use of next generation sequencing (NGS) for advanced cancer tests in recent comments, they want the agency to modify its approach to the NCD in one way or another and, in many cases, expand it. A final coverage decision is imminent.

Reimbursement Market Access
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