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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

HHS Pressured By Lawmakers To Release Pandemic-Flu Plan

Two House Committee leaders are asking HHS Secretary Tom Price about the current status of an overdue pandemic influenza preparedness plan, including diagnostic advancements, that was promised last August. The lawmakers say they are worried about a US return of the H7N9 avian influenza virus, which re-emerged in China earlier this year.

In Vitro Diagnostics Infectious Diseases

House Bill Clarifies CDRH Lead For New Imaging Indications For Devices Using Contrast

Rep. Ryan Costello, R-Pa., and Scott Peters, D-Calif., recently introduced legislation clarifying that the US FDA device center, rather than the drug center, will have primary authority to consider and clear new indications for imaging devices and technologies that use previously approved contrast agents.

Diagnostic Imaging Legislation

Senate, House Panels Release Clean Device User-Fee Discussion Draft

Lawmakers emphasized the need for a swift reauthorization of a combined US FDA device and drug user-fee reauthorization bill before the end of July, and released a clean discussion draft April 14 that mirrors the agreements reached by industry and the agency last summer.

FDA Legislation

Lab Professionals Oppose Draft Dx Reform Bill; Lab, IVD Industry Ready To Work With Congress

The clinical lab industry and IVD test-kit-makers appear ready to work with lawmakers on diagnostic reforms that would create a new category of regulated product for all lab tests that would undergo a mix of US FDA and CMS oversight. Meanwhile, key groups representing laboratory professionals remain fundamentally opposed to the concept.

Regulation Legislation

Philips' eICU Telemedicine Program Yields Cost Savings, Slows Readmissions For Emory

Five Emory University-affiliated hospitals taking part in a Philips eICU program cut total costs by $4.6m – or $1,468 per average care episode – reduced discharges to nursing homes by 6.9%, and lowered inpatient readmission rates, according to a recent audit by CMS contractors.

Reimbursement Medicare

Chronic Care Bill Would Pay Big Dividends In Telehealth Reimbursements

A bill introduced by four US Senators to address and improve chronic illness care will increase reimbursements for telehealth care of home-based patients on Medicare Advantage plans, permit beneficiaries in several accountable care organizations (ACO) to be furnished telehealth service at home, and expand the use of telehealth for individuals with stroke.

Policy Legislation
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