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BioWorld - Wednesday, November 12, 2025
Home » Topics » Europe, BioWorld MedTech

Europe, BioWorld MedTech
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Clinical research survey

France in pole position for clinical research with medical devices in Europe

April 17, 2020
By Bernard Banga
PARIS – The French Association of CROs (AFCROs) has published the third edition of its survey of clinical research in France. This tool is intended to provide an overview of clinical research in that country, along with any recent developments.
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WHO headquarters, Geneva

EU leaders pan Trump’s move to halt U.S. funding as WHO updates COVID-19 response plan

April 15, 2020
By Nuala Moran
LONDON - The director general of the World Health Organization has given a dignified and measured response to President Donald Trump’s decision to halt U.S. funding of WHO, pending a review of its handling of the coronavirus pandemic.
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4-9-Air-Liquide-ventilator.png

French manufacturing consortium to produce 10,000 ventilators in 50 days

April 9, 2020
By Bernard Banga
PARIS – Medical gases specialists Air Liquide SA, of Paris, along with Peugeot SA, Schneider Electric SE and Valeo SA have joined together in a consortium to manufacture ventilators in a time when there is a critical shortage.
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Abbott scores win as Triclip secures CE mark

April 9, 2020
By Liz Hollis
Abbott Laboratories, of Abbott Park, Ill., reported that its Triclip transcatheter tricuspid valve repair system has received the CE mark. The device is a nonsurgical treatment for people with tricuspid regurgitation (TR), and, according to the company, it is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available. The Triclip is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood.
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European Union map and coronavirus

EMA activates COVID-19 pandemic task force to galvanize European regulatory response

April 9, 2020
By Cormac Sheridan
DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.
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Australia’s Genetic Signatures garners CE mark for its Easyscreen PCR COVID-19 diagnostic

April 7, 2020
By Tamra Sami
PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. received the CE mark for its 3base Easyscreen SARS-CoV-2 detection kit, clearing the way for marketing across the EU.
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Oncosil-CEO-Kenny.png

Oncosil wins CE mark, breakthrough designation for pancreatic cancer device

April 1, 2020
By Tamra Sami
PERTH, Australia – The British Standards Institute (BSI) granted Sydney-based Oncosil Medical Ltd. European CE marking approval for its brachytherapy device to treat locally advanced pancreatic cancer in combination with chemotherapy, clearing the way for marketing in both the EU and the U.K. BSI also granted the Oncosil device breakthrough therapy designation.
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Europe under magnifier/petri dish with coronavirus

European IVD med-techs upping efforts to launch rapid COVID-19 screening tests

March 31, 2020
By Bernard Banga
PARIS – Europe has turned into the epicenter of the coronavirus pandemic, seeing more than 50% of the cases observed worldwide. In fact, whereas the COVID-19 pandemic has begun declining in China where it originated, there are 400,000 cases of coronavirus worldwide, including more than 200,000 infected by SARS-CoV-2 in the 55 sovereign states in continental Europe, where they are mourning more than 18,000 deaths.
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Coronavirus aiming for man carrying piggy bank

Smith+Nephew withdraws guidance amid COVID-19 uncertainty

March 30, 2020
By Liz Hollis
Citing the rapidly changing situation related to COVID-19, Watford, U.K.-based Smith+Nephew plc said it is withdrawing its 2020 outlook. It highlighted COVID-19’s spread beyond China, as well as the slow pace of recovery for elective procedures in that country.
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European Union flag

EU pulling the plug on MDR implementation

March 27, 2020
By Nuala Moran
LONDON – The European Commission (EU) is pulling the plug on implementation of the Medical Devices Directive (MDR) on May 26, to free up resources and expertise as countries across Europe struggle to deal with the COVID-19 crisis.
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