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BioWorld - Friday, December 12, 2025
Home » Topics » Regions » Europe

Europe
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DNA, dollars illustration

Base Genomics raises seed $11M for new DNA methylation liquid biopsy detection tech

June 5, 2020
By Nuala Moran
LONDON – Base Genomics Ltd. has raised $11 million in an oversubscribed seed round to commercialize a new liquid biopsy technology for detecting DNA methylation, invented in the U.K. at the Ludwig Institute for Cancer Research at Oxford University.
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Hamid Lamraoui headshot
Novel artificial urinary sphincter

Uromems raises $17.5M to advance development of its electronic artificial urinary sphincter

June 4, 2020
By Bernard Banga
PARIS – Uromems SAS, of Grenoble, France, reported the completion of a series B round of $17.5 million to advance development of its implantable mechatronic device for treating stress urinary incontinence.
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Map of Europe

Update to ISO 14155 delayed, alignment with EU MDR remains uncertain

June 4, 2020
By Mark McCarty
The implementation date for the EU’s new med-tech regulatory framework has been pushed back a year, giving device makers much-needed breathing room for compliance work. At the same time, the International Organization for Standardization (ISO) has not fulfilled the planned May update of its device clinical investigations standard, ISO 14155.
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Memed secures CE mark for new POC blood test

June 2, 2020
By Nuala Moran
LONDON – After eight years in development, Memed Diagnostics Ltd. has secured CE marking for its point-of-care blood test, which is able to distinguish between bacterial and viral infections in 15 minutes.
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Carmat’s artificial heart product image
Bioprosthetic artificial heart

Carmat obtains nod for reimbursement for its total artificial heart under innovation scheme in France

May 29, 2020
By Bernard Banga
PARIS – Carmat SA, which is based in Vélizy Villacoublay, France, reported the first implantation of its bioprosthetic artificial heart at the Heart Center of the Rigshospitalet in Copenhagen, Denmark.
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Heart illustration

Fineheart successfully completes study of its implantable device for treating severe heart failure

May 26, 2020
By Bernard Banga
PARIS – Fineheart SA, of Bordeaux, France, reported the success of a seven-day preclinical study to evaluate its Implantable Cardiac Output Management System (ICOMS), the first fully Intra-Ventricular Flow Accelerator synchronized to the native heartbeat to restore natural heart pumping capacity.
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Illustration of business bar chart being toppled by coronavirus

Medtronic sees quarterly revenue dip with deferral of procedures

May 21, 2020
By Liz Hollis
Like many other med-tech companies, Medtronic plc, of Dublin, saw COVID-19 affect its financial results for its fourth quarter and fiscal year 2020, as procedures were deferred in the wake of the pandemic. Quarterly worldwide revenue came in at $5.998 billion, representing a decrease of 26% as reported and 25% on an organic basis.
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Scientist injecting vaccine into Earth

Astrazeneca moving at Warp Speed with $1.2B in BARDA funding for COVID-19 vaccine

May 21, 2020
By Nuala Moran
LONDON – Astrazeneca plc is to get up to $1.2 billion from the new U.S. COVID-19 vaccines program, Operation Warp Speed, to support further development and manufacturing of a vaccine developed at Oxford University’s Jenner Institute. The company said it will begin to ship the product in September 2020, with the U.K. and U.S. first in line for deliveries.
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EMA’s Rasi laments fragmented clinical trial efforts targeting COVID-19

May 19, 2020
By Nuala Moran
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
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3D heart illustration showing tricuspid and bicuspid valves

Edwards receives CE mark for Pascal tricuspid repair to compete with Abbott’s Triclip

May 18, 2020
By Stacy Lawrence
Edwards Lifesciences Corp. has gained a CE mark for its Pascal transcatheter valve repair system to treat tricuspid regurgitation (TR). It was previously approved for mitral regurgitation treatment. Due to the pandemic, Edwards has paused new enrollments in its ongoing mitral and tricuspid pivotal clinical trials.
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