Live Breaking News & Updates on Ce mark

Stay informed with the latest breaking news from Ce mark on our comprehensive webpage. Get up-to-the-minute updates on local events, politics, business, entertainment, and more. Our dedicated team of journalists delivers timely and reliable news, ensuring you're always in the know. Discover firsthand accounts, expert analysis, and exclusive interviews, all in one convenient destination. Don't miss a beat — visit our webpage for real-time breaking news in Ce mark and stay connected to the pulse of your community

Front Line granted CE mark for smallest aortic occlusion device

Front Line Medical Technologies Inc. recently received CE mark for its Cobra-OS, the smallest REBOA (resuscitative endovascular balloon occlusion of the aorta) device for use in emergency situations on the market. The company believes that Cobra-OS could help save the lives of patients during traumatic bleeding situations as it could buy valuable time until definitive care can be provided.

Front-line-medical-technologies-inc , Front-line-medical-technologies , Bioworld-medtech , Cobra-os , Front-line-medical-technologies-inc- , Reboa , Ce-mark , Eu , Emergency-department , Regulatory , Europe

Biosense Webster continues PFA approval trend, nabs CE mark for Varipulse

Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation.

Johnson-biosense-webster-inc , Biosense-webster , Bioworld-medtech , Biosense-webster-inc- , Us- , Ce-mark , Johnson-amp , Boston-scientific-corp- , Medtronic-plc , Farapulse-inc- , Varipulse

Clarius receives CE mark for latest wireless ultrasound scanner

Clarius Mobile Health Inc. received CE mark for its latest wireless hand-held whole-body ultrasound scanner, the Clarius PAL HD3. The scanner combines both phased and linear arrays on a single head which provides high image quality of superficial and deep anatomy allowing for better diagnostic capabilities and patient care.

Clarius-mobile-health-inc , Clarius-mobile-health , Helmholtz-diabetes-center , Cachexia , Cancer-induced-cachexia , Penx-acip , Bioworld-medtech , Ce-mark , Clarius-mobile-health-inc- , Clarius-pal-hd3 , Point-of-care-diagnostics

EU continues struggle with rollout of new device regs in 2023

Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.

European-union-eu-medical-device-regulation , European-union , Medical-device-regulation , Ce-mark , Mdr , Ivdr , Mdcg , Notified-bodies ,

Biospectal receives CE mark for blood pressure monitoring app

Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure.

Ce-mark , Biospectal-sa , Blood-pressure , Remote-monitoring , Hypertension , Optibp ,

How to have a Hell of a good — and safe — time at Halloween

There is plenty of potential for Halloween pitfalls, from fireworks and bonfires to button batteries and allergies... here's how to look after your kids at this time of year

Ireland , Crumlin , Donegal , Ciara-martin , Carol-blackburn , Young , Emergency-department , National-standards-authority-of-ireland , Consumer-protection-commission , Hospital-ireland , National-standards-authority , Arenting

Medtronic gets CE mark for Simplera continuous glucose monitor

In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA approval for Medronic’s Minimed 780G insulin pump system earlier in the year. Simplera is an all-in-one disposable CGM sensor which features a two-step insertion process and will help patients who must have multiple daily injections (MDI) manage their diabetes.

Medronic-minimed , Medtronic , Cgm , Continuous-glucose-monitoring , Diabetes , Medtronic-inc- , Simplera , Insulin-pumps , Ce-mark ,

Medtronic wins CE mark for closed-loop spinal cord stimulator

The European Commission has granted CE mark approval to Medtronic plc for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). The device is the first Medtronic SCS to sense an individual’s biological cues and make adjustments in real time to control pain all day long. Dublin-based Medtronic plans to launch Inceptiv in Europe in the coming months.

Medtronic , European-commission , Medtronic-plc , Ce-mark , Spinal-cord-stimulator , Inceptiv , Closed-loop-system , Saluda-medical-pty-ltd- , Evoke , Neuromodulation , Pain-management

The EC releases update on MDR-IVDR applications and certification

The European Commission’s (EC’s) Directorate-General for Health and Food Safety recently published a survey of notified bodies. This was conducted between April and May 2023, eliciting responses from all 39 notified bodies designated under the Medical Devices Regulation (MDR) and 10 Notified bodies designated under the In Vitro Diagnostic Regulation (IVDR).

European-commission-ec-directorate , European-commission , Food-safety , Medical-devices-regulation , Vitro-diagnostic-regulation , Amending-regulation , Applications , Ivdr , Mdr , Certifications , Dg-sante

Misleading CE Mark Documentation Certification Issued by Real Companies

Following an LFA verification of a Recipient’s procurement, the QA Team would like to bring to the attention of the procurement community that certain Personal Protective Equipment (PPE) products and medical devices, and related documents, prominently display the CE mark logo whereas the products have not been verified as meeting European procedures.

Global-fund-quality-assurance , Real-companies , Qa-team , European-safety-federation , Documentation-certification-issued , Personal-protective-equipment , Medical-device , Ente-certificazione-macchine , Quality-assurance , Ce-mark , Ocumentation