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23.06.2025
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Urgent Field Safety Notice for Venclose EVSRF Catheter by Venclose, Inc.
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 36336/24
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23.06.2025
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Urgent Field Safety Notice for CareLink SmartSync Platform (iOS) (Common App, Host, Device Manager, Base, Softwarekomponenten) by Medtronic Inc
Product group Active implantable medical devices -
defibrillators
Reference 26815/25
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23.06.2025
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Urgent Field Safety Notice for Sheath by Trokamed GmbH
Product group Medical instruments for use in humans -
visceral surgery
Reference 23237/25
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23.06.2025
|
Sodium oxybate: Review of use in alcohol dependence
Active substance: odium oxybate
The European Medicines Agency (EMA) is starting to review medicines containing sodium oxybate.
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20.06.2025
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New radiation protection regulations effective July 1, 2025
Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.
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20.06.2025
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Approval procedure pursuant to Section 31 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025
The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.
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20.06.2025
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Notification procedure pursuant to Section 32 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025
This article provides information on the correct procedure for reporting a notification procedure in accordance with Section 32 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) as part of CTR submission and for Substantial Modifications in CTIS.
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18.06.2025
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Urgent Field Safety Notice for ADVIA 120/2120/2120i SETpoint Calibrator by Siemens Healthcare Diagnostics Inc. Tarrytown
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 25266/25
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18.06.2025
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Capacity building at its best: seeding and harvesting
This report highlights two key milestones: the recent manual workshop in Tanzania and the first continental clinical assessment training – both of which underscore the fellowship's commitment to capacity-building and harmonization across the African continent.
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17.06.2025
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Urgent Field Safety Notice for One-piece Guedel airways by Intersurgical Ltd.
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 25677/25
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17.06.2025
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Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
Product group Radiotherapy / Radiation protection -
radiotherapy treatment planning systems
Reference 10321/24
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16.06.2025
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Urgent Field Safety Notice for NIO-A by WaisMed Ltd.
Product group Injections / Infusions / Transfusions / Dialysis -
syringes and cannulas
Reference 24142/25
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16.06.2025
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Urgent Field Safety Notice for FUßSCHALTER 2 PEDALE L 5M by Richard Wolf GmbH
Product group Medical electronics / Electromedical devices -
electrotherapy
Reference 25681/25
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16.06.2025
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Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
Product group Medical data processing (software) -
others
Reference 19784/25
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16.06.2025
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Urgent Field Safety Notice for Atlas, Titan, Orian, Elan, Galan, Centurian etc. by Canon Medical Systems Corporation
Product group Electromedical fields -
equipment for MR tomography
Reference 25917/25
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16.06.2025
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Urgent Field Safety Notice for SafeStar Plus, TwinStar HEPA Plus by Drägerwerk AG & Co. KGaA
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 20838/25
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16.06.2025
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CHMP Meeting Highlights May 2025
CHMP Meeting Highlights May 2025
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16.06.2025
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CHMP Meeting Highlights June 2025
CHMP Meeting Highlights June 2025
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16.06.2025
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CHMP Meeting Highlights July 2025
CHMP Meeting Highlights July 2025
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13.06.2025
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Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
Product group Medical data processing (software) -
others
Reference 18718/25
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