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BioWorld - Monday, April 6, 2026
Home » Topics » Europe, Medical technology

Europe, Medical technology
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Ziwig Endotest

France grants Ziwig Endotest fast-track reimbursement

Feb. 13, 2025
By Annette Boyle
Ziwig SAS, which leads the race for a simple diagnostic for endometriosis, picked up the pace with a fast-track reimbursement decision in France for its Endotest, the first saliva-based diagnostic assay for endometriosis.
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European Union flag with wooden gavel

EC drops AI liability directive for now

Feb. 12, 2025
By Mark McCarty
The European Commission’s proposal for an AI-specific liability law seemed destined to pile onto existing EU liability law, but the commission reported it will pull the legislative proposal dubbed the AI Liability Directive.
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Shipping container with flag of China

Speculations rise on US tariff impact on global pharma industry

Feb. 11, 2025
By Marian (YoonJee) Chu
For the pharmaceutical industry caught in the crosshairs of a potential trade war, the consequences of U.S. tariffs on China or Europe remain largely speculative, although both would be detrimental, according to a Korea Biotechnology Industry Organization (KoreaBIO) issue briefing Feb. 7.
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DBS for stroke

Newronika gets IDE from the FDA for adaptive DBS trial

Feb. 11, 2025
By Shani Alexander
Newronika SpA's AlphaDBS recently secured an investigational device exemption from the U.S. FDA allowing it to begin a pivotal trial to evaluate the safety and efficacy of its adaptive deep brain stimulation system in patients with movement disorders, including Parkinson's disease.
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Artificial intelligence and digital health icons

European Commission provides guidance for AI Act

Feb. 11, 2025
By Mark McCarty
The European Commission issued a set of guidelines for the use of AI as a supplement to the EU’s Artificial Intelligence Act, a document of which chatbot developers will want to take note.
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United Kingdom flag, map

NICE to revisit its cost savings approach to health tech assessment

Feb. 11, 2025
By Mark McCarty
The U.K.’s National Institute for Health and Care Excellence (NICE) historically relies on cost savings to vet novel medical technologies, but that may soon change per a Feb. 7 announcement.
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Squamous cell carcinoma.

Skin Analytics DERM gets CE mark for autonomous cancer detection

Feb. 10, 2025
By Shani Alexander
Skin Analytics Ltd. received CE mark for its AI-based tool Deep Ensemble for the Recognition of Malignancy (DERM), which can assess images of lesions and detect skin cancer autonomously. The technology has an accuracy rate of 99.8% compared to 98.9% for dermatologists.
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Shipping container with flag of China

Speculations rise on US tariff impact on global pharma industry

Feb. 7, 2025
By Marian (YoonJee) Chu
For the pharmaceutical industry caught in the crosshairs of a potential trade war, the consequences of U.S. tariffs on China or Europe remain largely speculative, although both would be detrimental, according to a Korea Biotechnology Industry Organization (KoreaBIO) issue briefing Feb. 7.
Read More
Reev Dreeven exoskeleton

Reev secures $9.2M for lightweight exoskeleton

Feb. 7, 2025
By Shani Alexander
Reev SAS raised $9.2 million in a financing round that will fund further development of its lightweight exoskeleton Dreeven.
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Gold Euro symbol on blue background

European VCs optimistic for med-tech exit opportunities in 2025

Feb. 6, 2025
By Shani Alexander
To say that European investors are optimistic about the outlook for the med-tech sector in 2025 is an understatement. A couple of companies are already listed on public markets, acquisitions have been undertaken and med-tech players with cash-rich balance sheets are on the hunt.
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