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BioWorld - Saturday, April 25, 2026
Home » Topics » Regions » Europe

Europe
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UK and EU clear Artrya’s AI-enabled Salix coronary anatomy software

Nov. 17, 2022
By Tamra Sami
After getting its 510(k) application rejected by the U.S. FDA for its AI-enabled Salix coronary anatomy software (SCA), Australian medical technology company, Artrya Ltd. scored regulatory approvals in the UK and in the EU.
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CHU Toulouse

Surgeons reconstruct patient’s nose using entirely 3D-printed ceramic implant

Nov. 16, 2022
By Bernard Banga
Surgical teams from the Department of Oncology at Toulouse University Hospital and the Cancer University Institute of Toulouse Oncopole have achieved a total reconstruction of a patient’s nose using a 3D-printed synthetic graft previously implanted in her forearm to pre-vascularize it.
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Esophageal cancer

Junshi steps up efforts in Europe by filing for the NDA of toripalimab

Nov. 16, 2022
By Doris Yu
Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.
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UK map and pharmaceuticals

NICE says no to five COVID-19 treatments in the UK

Nov. 16, 2022
By Lee Landenberger
Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc.
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Pancreas illustration

Details matter: Medtronic innovation reduces insulin costs 25%

Nov. 15, 2022
By Annette Boyle
Medtronic plc’s new Extended infusion set shows the advantages of tending to details. Tubing doesn’t get much respect, but the changes Medtronic made to its set will substantially reduce the burden of disease management for patients with diabetes who use insulin pumps. The Medtronic Extended infusion set can be used for up to seven days, more than doubling the time between changes. The changes also sharply reduced insulin loss, resulting in a 25% reduction in waste of the increasingly expensive medication.
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French government sets up innovation agency to support medical devices of the future

Nov. 14, 2022
By Bernard Banga
The government in France has just launched the Health Innovation Agency. This new government agency aims to improve identification of future health technology and better anticipate the impact of innovation in France.
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Histologue Scanner

Histolog scanner demonstrates reduction in breast surgery re-operation rates of up to 75%

Nov. 10, 2022
By Bernard Banga
Samantree Medical SA has published clinical data demonstrating a significant reduction in re-operations in breast-conserving surgery using its novel ultra-fast confocal microscopy technology. The study on its medical imaging platform, the Histolog scanner, has just been published in The Breast.
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United Kingdom flag, map

NICE proposes an endorsement of digital tech for pediatric anxiety

Nov. 9, 2022
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) has opened a consultation on the use of five digital health products that can be used to help children and adolescents better manage anxiety or low mood.
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EU flag and light bulb

EFPIA: Time for Europe to regain its Rx innovation

Nov. 8, 2022
By Mari Serebrov
Europe is losing its innovative edge in biopharma, especially when it comes to advanced therapy medicinal products, including tissue, gene and cell therapies used to prevent, treat and cure rare conditions and some cancers.
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Diagnostic Medical Systems manufacturing site

DMS spins off Hybrigenics to concentrate on core imaging business

Nov. 3, 2022
By Bernard Banga
Diagnostic Medical Systems Group SA (DMD) is selling its entire stake in the share capital of Hybrigenics SAS, a biotech company listed on the Paris Euronext Stock Exchange since 2007. This sale of 116,911,328 shares, representing 43.41% of Gard, France-based Hybrigenics’ share capital, will allow DMS Group to refocus on its core imaging business. “We will strengthen our free cash in order to ramp the launch of new technology in medical imaging,” Samuel Sancerni, CEO of Diagnostic Medical Systems, told BioWorld.
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