Tag: CE mark

Axonics receives CE-mark approval for fourth-generation rechargeable SNM therapy

Axonics has announced that the Axonics R20 rechargeable sacral neuromodulation (SNM) system has received CE-mark approval. Axonics expects to commence sales of the R20 to...

Medtronic announces first neurointerventional case with CE-marked Rist 6Fr radial access...

Medtronic has announced the first neurointerventional case in Europe with its Rist 6Fr radial access catheter, which recently received regulatory approval for use in...

InspireMD receives CE-mark recertification under new EU regulatory framework

InspireMD announced today that it has received CE-mark recertification under the European Union’s (EU) new Medical Device Regulation (MDR) regulatory framework for its CGuard...

Medtronic receives CE-mark approval for Inceptiv closed-loop SCS to treat chronic...

Medtronic has received CE-mark approval for its Inceptiv closed-loop rechargeable spinal cord stimulator in the treatment of chronic pain. Inceptiv is the first Medtronic spinal...

Q’Apel Medical granted CE-mark approval for Walrus balloon guide catheter

Q'Apel Medical has been granted a CE mark under the European Medical Device Regulation (MDR) for Walrus, its balloon guide catheter (BGC) product used...

Methinks receives CE-mark certification for AI-based stroke triage software

Methinks has announced receipt of a CE mark for its artificial intelligence (AI)-based medical imaging software, Methinks Stroke Suite, following a milestone year of...

Infinity Neuro receives CE-mark approval for aspiration catheter to treat stroke

Infinity Neuro announced today that its Inspira aspiration catheters have received CE-mark approval and are now commercially available in Europe. This is the first offering from...

iVascular launches new neurovascular portfolio with four CE-marked devices

Vascular device company iVascular has announced the expansion of its therapeutic areas with the launch of a new neurovascular pipeline, having gained CE-mark approval...

Aleva Neurotherapeutics gains European MRI approval for deep brain stimulation system

Aleva Neurotherapeutics has announced CE-mark approval of its magnetic resonance imaging (MRI) labelling for the directSTIM deep brain stimulation (DBS) system, allowing the technology...

Penumbra announces European launch of RED reperfusion catheters for stroke care

Penumbra announced today that its RED reperfusion catheters have secured a CE mark and are now commercially available in Europe. The catheters are part of...

Vesalio gains CE-mark approval for new “one-of-a-kind” NeVa NET thrombectomy device

Vesalio has today announced receipt of CE-mark approval for commercialisation of its new NeVa NET, which the company claims is the “first and only”...

SyncThink secures CE mark for EYE-SYNC digital health platform

SyncThink announced today that it has gained CE-mark certification for its EYE-SYNC technology, affirming conformity to the European Medical Device Regulation (MDR). EYE-SYNC will...

Wyss Center announces CE mark for Epios Cloud brain data visualisation...

The Wyss Center has announced CE mark Class I medical device approval for its Epios Cloud software—a web-based application for the online storage, processing...
Medtronic receives CE mark approval for radial artery access portfolio

Medtronic receives CE mark approval for radial artery access portfolio

Medtronic today announced it has received CE mark approval for its radial artery access portfolio, which includes the Rist radial access selective catheter and the Rist...

Viz.ai receives CE mark to bring AI-powered stroke care software to...

Viz.ai has been awarded a CE mark for its artificial intelligence (AI)-powered stroke care software, affirming its conformity with European health, safety and environmental...
stroke severity assessment ai

Avicenna.AI receives CE mark for AI tool to assess stroke severity

Medical imaging AI specialist Avicenna.AI has received CE mark certification for its CINA ASPECTS AI tool for stroke severity assessment. CINA ASPECTS automatically processes...
chordate medical

Chordate Medical receives CE mark to treat chronic migraine with neuromodulation...

Chordate Medical has received a CE marking that permits its Kinetic Oscillation Stimulation (KOS) technology to be marketed, sold and used for the treatment...
perfuze millipede 088

Perfuze announces CE mark and treats first patients with Millipede 088...

Neurovascular medical device company Perfuze has announced that the first five acute ischaemic stroke patients have been treated with its Millipede 088 clot aspiration...

PreSize Neurovascular software launched at first UK NHS hospital

Doctors at St George’s Hospital in London, UK are set to become the first within the UK National Health Service (NHS) to begin using Oxford Heartbeat’s...
021 Contour Cerus endovascular

CerusEndo MC 021 microcatheter wins CE mark

Cerus Endovascular has announced that it has received CE mark approval for its CerusEndo MC 021 microcatheter, designed to allow physicians to access tortuous...
Squid trial embolisation balt

Balt receives CE mark for its Silk Vista flow diverter

Balt has received CE mark approval for its Silk Vista flow diverting stent to treat patients with unruptured intracranial aneurysms, in turn enabling commercialisation...
021 Contour Cerus endovascular

Cerus Endovascular’s 021 Contour neurovascular system approved in Europe

Cerus Endovascular has received CE Mark approval for its 0.021-inch Contour neurovascular system, compatible with smaller commercially available 021 microcatheters for the treatment of...
Efficio launch

Medtronic receives CE mark for InterStim Micro Neurostimulator and InterStim SureScan...

Medtronic has announced it has received CE mark for its InterStim Micro neurostimulator and InterStim SureScan MRI leads—clearing the technologies for commercial sale and...

Medtronic receives CE mark approval for the Percept PC Neurostimulator deep...

Medtronic announces the CE mark for Percept PC neurostimulator. It is the only Deep Brain Stimulation (DBS) system to be launched in the European...
Cascade Perflow Medical

Perflow Medical receives CE mark approval of Cascade Agile

Perflow Medical has announced they have received CE Mark approval for the Cascade Agile non-occlusive remodelling net (Cascade Agile). Expanding the Cascade product family,...
CorPath GRX Corindus

Corindus announces regulatory approval of CorPath GRX for neurovascular intervention in...

Corindus Vascular Robotics has announced that it received approval from the Australian Therapeutic Goods Administration to commercialise its CorPath GRX System for neurovascular interventions...
neurolief

The first non-invasive, adaptive neuromodulation digital treatment for migraine receives CE...

Neurolief, a developer of digital therapeutics brain neuromodulation technology, has announced that it has received the CE mark for its Relivion non-invasive, adaptive digital treatment...
Aperio

APERIO hybrid thrombectomy device receives CE mark approval

Acandis GmbH announces that it has received European CE mark approval for its APERIO hybrid thrombectomy device. APERIO is intended for restoration of the...
Vesalio NeVa

Vesalio obtains additional CE approval for new products with NeVa clinical...

Vesalio has announced that it has obtained its second CE approval spanning multiple new NeVa product designs and technology. The new generation NeVa devices...
Squid trial embolisation balt

Balt USA announces CE mark obtained for Titan aspiration catheter

Balt USA has announced that it has obtained CE mark for the Titan aspiration catheter. The Titan catheter line consists of a highly navigable,...

Neuromod prepares for global commercialisation of Lenire tinnitus treatment

Neuromod Devices, the Irish medical technology company specialising in non-invasive neuromodulation technologies, has provided an update on organisational and leadership growth in preparation for...

Insera earns CE mark approval for cyclical-suction stroke thrombectomy platform, the...

Insera Therapeutics has announced that it has received CE mark approval for its flagship product, the CLEAR Aspiration System, for the aspiration of blood...

Balt announces receiving CE marks for Ballast .088 Long Sheath

Balt International has announced receiving the CE mark for the Ballast .088 Long Sheath. The Ballast .088 Long sheath is indicated for the introduction...