Topic: CE Mark

Dive Brief: TÜV SÜD has suspended the CE certificate for Getinge’s intra-aortic balloon pump Cardiosave […]

Medtronic said it has received Europe’s CE mark for its Affera system that integrates pulsed […]

Methinks has announced receipt of a CE mark for its artificial intelligence (AI)-based medical imaging […]

Hyperfine has gotten the green light to take its talents to the EU—but whether the […]

Innovation Zed announced that it received CE mark approval in Europe for its InsulCheck Dose […]

Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Aurora EV-ICD and Epsila […]

The European Parliament on Thursday voted overwhelmingly to delay implementation of the new Medical Device […]

EndoStream Medical has announced that the first patient has been enrolled in the TORNADO-US clinical study in […]

Fractyl Health announced today that it commercially launched its Revita DMR system for diabetes reversal […]

Asensus Surgical is poised to take a bigger piece of the surgical robotics pie in […]

Activ Surgical announced today that it received CE Mark approval for its ActivSight Intelligent Light. ActivSight […]

Thubrikar Aortic Valve, a privately held medical device company, recently announced the completion of the initial CE […]

Medtronic announced not one, not two, but three significant regulatory approvals for its Hugo robotic-assisted […]

The CE-IVD marked TaqPath Enteric Bacterial Select Panel, recently introduced by Thermo Fisher Scientific, detects […]

Acurable, a UK-based medical device company, announced it raised €11 million ($10.8 million) in a […]

ClearPoint Neuro (Nasdaq: CLPT) announced today that the FDA has cleared its Swedish partner Clinical […]

On the heels of launching Omnipod 5 in the United States, Insulet has received CE marking […]

Aleva Neurotherapeutics has announced CE-mark approval of its magnetic resonance imaging (MRI) labeling for the […]

Penumbra announced today that its RED reperfusion catheters have secured a CE mark and are […]

Dive Brief: Medtronic has begun to sell its latest drug-eluting stent, Onyx Frontier, in Europe after securing […]

Dive Brief: Edwards Lifesciences received a CE mark for its Pascal Precision system, its newest […]

One of medtech’s most anticipated devices is facing yet another delay in obtaining FDA clearance. […]

Caption Health recently announced it has received a CE Mark for its Caption AI (artificial intelligence) technology […]

Empirical Spine recently had its pre-market approval (PMA) Module II accepted and closed by the […]

Elucid, a medical technology company out of Boston, MA, said it will commercialize its AI-based […]

Dive Brief: Senseonics has received a CE mark for its six-month Eversense E3 continuous glucose monitoring implant, […]

Singapore-based medtech company Us2.ai is expanding to Europe after receiving a CE mark for its […]

Singapore-based MedTech company Us2.ai is expanding to Europe after receiving a CE mark for its […]

DoMore Diagnostics announced that it received CE mark approval in Europe for its Histotype Px […]

Point of care NGS diagnostics firm, LumiraDx Limited, has achieved CE Mark for its SARS-Cov-2 […]

Hologic received approval from the Food and Drug Administration for an assay to quantify the viral load of […]

Dexcom (Nasdaq:DXCM) published new data highlighting the accuracy of the next-generation G7 continuous glucose monitor […]

Optellum announced that it received CE mark for its artificial intelligence (AI)-powered Virtual Nodule Clinic software […]

Dexcom (Nasdaq:DXCM) announced today that it received CE mark approval in Europe for its G7 […]

Roche announced today that it launched its Cobas Pulse system in select countries accepting CE mark […]

The fast-growing minimally invasive glaucoma surgery (MIGS) market just got a new contender.

Baxter (NYSE:BAX) and Biomérieux (EPA:BIM) today announced CE mark approval for the Nephroclear CCL14 test. The companies designed […]

Intuitive isn’t the only game in town anymore. Medtronic has been awarded CE mark for its Hugo Robotic-Assisted Surgery system.

Medtronic today said it has received CE mark approval for its radial artery access portfolio. […]