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Senior reporter
Washington DC, USA
15+ years of 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
By Sue Darcey 16 Jun 2022
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
By Sue Darcey 29 Nov 2020
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
By Sue Darcey 27 Nov 2020
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 Approvals Clinical Trials Coronavirus Policy & Regulation
Medtech Insight
By Sue Darcey 27 Nov 2020
The US agency says it will not object to medtech manufacturers making minor modifications to the motors, tubing or software of medical ventilators – or even to pressing CPAP (continuous positive airway pressure) equipment into service to use as ventilators – during the COVID-19 public health emergency.
Topic Coronavirus Medtech
Medtech Insight
By Sue Darcey 27 Nov 2020
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 Approvals Clinical Trials Coronavirus Policy & Regulation
Medtech Insight
By Sue Darcey 18 Nov 2020
A few of the US Senate candidates favored and given tens of thousands of dollars by industry have lost their battles for re-election
Topic US Election 2020 Legislation
Medtech Insight
By Sue Darcey 29 Oct 2020
US senatorial friends of the device industry running competitive races in 2020 are being aided by medtech PAC dollars this fall
Medtech Insight
By Sue Darcey 05 May 2020
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
By Sue Darcey 30 Mar 2020
A $2.2tn coronavirus stimulus package signed into law by President Trump on 27 March will distribute billions of dollars to federal agencies – including the FDA, the CDC and the FEMA – to hasten approvals of new diagnostics, medical ventilators, respirators and other medtech supplies, conduct more testing of potential COVID-19 patients, and quickly distribute medical supplies where needed most.
Topic Coronavirus
Medtech Insight
By Sue Darcey 12 Mar 2020
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
By Sue Darcey 07 Feb 2020
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
By Sue Darcey 30 Jan 2020
A new coronavirus test template developed by the US Centers for Disease Control and Prevention is being refined by the agency so it can be shared with domestic and international partners to help identify more cases of the virus. In the meantime, state labs can use the posted assay for coronavirus on the CDC’s website for testing of residents within their jurisdiction and send results to the CDC.
Topic Coronavirus Emerging Markets Policy & Regulation Safety
Medtech Insight
By Sue Darcey 13 Nov 2019
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 & Regulation
Medtech Insight
By Sue Darcey 13 Nov 2019
While a government agency shutdown due to lack of agreement between Congress and the Trump administration over funding for the US Food and Drug Administration and other federal agencies seems less likely this year than last, the FDA will still have carry out its 2020 mission in the short term on 2019 continuing resolution funding – probably through December – legislative experts say.
Topic FDA Policy & Regulation
Medtech Insight
By Sue Darcey 14 Aug 2019
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
01 Mar 2021
Medtech Insight
26 Feb 2021
Medtech Insight
25 Feb 2021
Medtech Insight
23 Feb 2021
Medtech Insight
22 Feb 2021
Medtech Insight
19 Feb 2021
Medtech Insight
18 Feb 2021
Medtech Insight
18 Feb 2021
Medtech Insight
16 Feb 2021
HBW Insight
15 Feb 2021
Medtech Insight
12 Feb 2021
HBW Insight
11 Feb 2021
Medtech Insight
11 Feb 2021
Medtech Insight
09 Feb 2021
Medtech Insight
08 Feb 2021
