Sue Darcey
Senior reporter
Washington DC, USA
+14 year(s) experience
A Washington DC-based trade journalist with over 30 years' experience covering Capitol Hill and regulatory agencies including FDA, CMS and the EPA, Sue is constantly on the look-out for any new laws, regulations, challenging device and test makers, and ways that firms resolve those issues. She also writes extensively about CMS changes to paying providers for their value-based practices, rather than on a fee-for-service basis, and how the changes affect device reimbursements.
When Sue is not covering the US Congress, CMS, and the medtech industry, she likes to be outdoors, where she can be found birding, hiking, gardening, swimming, and taking photos of flora and fauna of the US mid-Atlantic region.
Medtech Insight: 世界の医療機器・医療技術の最新情報
Health policy changes that President-elect Joe Biden will likely make during his four-year term include Medicaid expansion and a greater reliance on medical science, among others, experts say.
Medtech Insight: 世界の医療機器・医療技術の最新情報
The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.
Topic drug-approval clinical-trials Coronavirus policy-and-regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.
Topic drug-approval clinical-trials Coronavirus policy-and-regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
Out of 31 US House incumbents supported by high amounts of medtech industry political action committee (PAC) dollars, only one – Chrissy Houlahan of Pennsylvania – lost in last week’s election.
Medtech Insight: 世界の医療機器・医療技術の最新情報
A negative COVID-19 antibody or serology test, even when authorized by FDA, is a poor indicator of whether an individual currently has or is completely immune from contracting coronavirus, the agency said on 4 May, issuing an updated guidance to drive the lesson home.
Medtech Insight: 世界の医療機器・医療技術の最新情報
An $8.3bn “Coronavirus Preparedness and Response Supplemental” funding act approved by the US Congress last week and signed into law on 6 March provides dollars and lays out the roles federal agencies, such as the FDA, and state and local agencies must play in containing and controlling the spread of COVID-19.
Topic Coronavirus
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
The US agency on 4 February issued its first Emergency Use Authorization of a 2019-novel coronavirus test by enabling emergency use of the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The move will allow use of the test at any CDC-qualified lab across the US.
Topic Coronavirus
Medtech Insight: 世界の医療機器・医療技術の最新情報
US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.
Topic FDA Policy and regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
The US Medicare agency has been scrutinizing two new devices that have generated some buzz within the industry for pass-through payment status under its proposed 2020 Outpatient Prospective Payment System (OPPS) rules. The devices are Procept BioRobotic’s AquaBeam System for removal of prostate tissue in men with urinary tract symptoms, and Boston Scientific’s Eluvia drug-eluting stent for treatment of peripheral artery disease.
Topic Medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
US Senate Finance Committee leaders say some physicians may have failed to disclose their physician-ownership interests in entities that offer medical supplies to the physician’s own practice, as required under the Physician Payment Sunshine Act. The legislators on March 19 prodded the Health and Human Services' Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) to take a closer look into these arrangements.
Medtech Insight: 世界の医療機器・医療技術の最新情報
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.
Topic reimbursement
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