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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

Bills Supporting Device Opioid Alternatives Advance In House

The House Energy and Commerce Committee approved four opioid crisis-related bills that call for US FDA meetings and consideration of streamlined pathways for medtech alternatives to opioids, and for a report and action by the US Medicare agency on overcoming payment challenges to device pain control products.

Legislation Policy

Industry Gives US Trade Rep 12 Reasons Why Tariffs on Chinese Medtech Imports Are A Bad Idea

The US Trade Representative office's decision in March to include devices, imaging machines and diagnostics on a list of Chinese imports destined for a 25% tariff has riled up the industry. A half-dozen medtech organizations protested the move in comments and testimony this week, supplying USTR with 12 reasons why the tariffs are a very bad idea.

Trade Policy

No New Regulations Needed For Third-Party Servicers Of Devices, FDA Says

There is “not sufficient evidence” of a widespread public health concern relating to servicing of devices, including by third-parties, according to an FDA report; the agency sees no immediate needs to issue new regulatory requirements for the third-party servicers. The agency also intends to issue guidance to help clarify the difference between “servicing” and “remanufacturing."

Diagnostic Imaging Quality

Labs, Test Makers Urge Congress To Pass Diagnostic Reforms

More than 80 industry, laboratory, health-care provider and patient groups sent a letter to two congressional committees, urging them to advance a bill to modernize the current way FDA regulates diagnostic tests, including possibly a new regulated product category that combines laboratory developed tests and in vitro diagnostics.

In Vitro Diagnostics Legislation

CMS To Raise Durable Medical Equipment Fees In No-Competitive-Bid Rural Areas

The US Centers for Medicare and Medicaid Service issued an interim final rule to shore up durable medical equipment prices in rural and noncontiguous areas of the US (including Alaska, Hawaii and territories) that are not subject to competitive bidding.

Reimbursement Policy

Advancing Bill Would Require Medicare Plans To Highlight Device Opioid Alternatives

The House Energy and Commerce Committee on May 9 approved, and sent to the full chamber, a bill requiring Medicare Part D drug plans to highlight information for prescribers on covered non-opioid pain devices and alternative medications.

Reimbursement Regulation
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