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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

US FDA Approves First Telehealth Option To Remotely Program Cochlear Implants

FDA approved a PMA supplement to remotely program sessions for Cochlear Americas' Nucleus Cochlear Implant System, heralding the feature as the first programming telehealth option for the hearing implants.

Ear, Nose & Throat Approvals

Medtech To Benefit From 20% Corporate Rate, Tax-Free Foreign Transfers In Pending US Tax Bill

Medical device firms will benefit from a Republican tax bill that has passed the full US House and a key Senate committee. The bill lowers the corporate tax rate to 20% from a maximum of 35%, treats foreign-earned intangible income at a favorably low rate of 12.5%, and permits tax-free transfers of intangible corporate property, such as patents, from foreign firms to US parents.

Legislation Trade

FDA Beefs Up Its UDI Direct-Marking Preferences In Final Guidance

US FDA's device center has made some clarifications to the way it would like to see sponsors directly mark medical devices intended to be reprocessed and reused, and it has beefed up its preferred approach to Unique Device Identification labeling in a final guidance on direct UDI marking released Nov. 16.

Regulation Quality Control

Neurostimulator Is First Device Marketed To Reduce Opioid Withdrawal Symptoms

FDA used its de novo pathway to clear Innovative Health Solution's NSS-2 Bridge – the first device for use in helping to reduce the symptoms of opioid withdrawal – as a class II device.

Neurology Regulation

Remote-Monitoring Code Added, Clinical Lab Fee Payments Set In Medicare Physician Pay Schedule

US CMS added a telemedicine code, finalized payments for clinical labs, and gave more time for physicians to adapt to its Medicare appropriate-use criteria (AUC) program for advanced diagnostic imaging, as part of its recently released physician fee schedule for 2018.

Market Access Reimbursement

Cybersecurity Threats Top ECRI's 2018 Health Tech Hazards List

ECRI Institute's latest annual top-10 list of "health technology hazards" list names "ransomware and other cybersecurity threats" as the number-one hazard. In fact, several items on the 2018 list point to safety risks emanating from the "digital aspects" of patient care and hospital operations.

Cybersecurity Safety
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