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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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Teamsters Ask Stockholders To Replace Cardinal Health Chairman

The International Brotherhood of Teamsters say that Cardinal Health CEO George Barrett failed to set the correct "tone at the top" while the firm became embroiled in the opioid epidemic and allegedly overpaid its chief compliance officer for illicit sales. The group is asking shareholders to appoint an independent board chairman, stripping Barrett of the role.

Leadership Medical Device

Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation

Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.

Advisory Committees Clinical Trials

Trump Rollback Of ACA Birth-Control Coverage Mandate To Push Down Gains In IUD Sales

More religious-based college employers, and for-profit businesses with moral objections to contraceptive coverage, will be able to issue health plans denying intrauterine device and birth control coverage to their employees and students starting in 2018, under the administration's Oct. 6-issued "conscience rights" exemptions from Affordable Care Act (ACA) requirements. The interim final rules could dampen sales of IUDs and implants that have risen 5% in the last year at Bayer Healthcare and Allergan.

Gynecology & Urology Market Access

Lack Of Device Identifiers On Recalled Cardiac Devices Cost Medicare $1.5Bn, OIG Says

Medicare lost $1.5bn in claims over a 10-year period to cover procedures to fix or replace seven faulty cardiac devices due to the lack of product-specific information on its claims form for malfunctioning defibrillators and pacemakers, says the US HHS Office of Inspector General. Recalls of Medtronic, Boston Scientific and Abbott/St. Jude Medical cardiac rhythm management devices are likely behind most of the cost.

Cardiology Product Recalls

HHS Secretary Tom Price Resigns Over Free-Flights Flap

US Health and Human Service Secretary Tom Price resigned Sept. 29 following controversy over free flights on military and private jets. Price, a former orthopedic surgeon and Georgia congressman, had initiated a reset of Obama-era payment reforms and oversaw an active FDA commissioner during his short tenure.

Policy Appointments

Abbott Gains Go-Ahead For First 'No-Fingerstick' CGM

Abbott Laboratories' Freestyle Libre Flash is the first continuous glucose monitoring system to gain US FDA approval that lets diabetics avoid the additional step of fingerstick calibration to measure their glucose levels, "with the wave of a mobile reader," the agency says.

Diabetic Care Approvals
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