(Nasdaq: HOLX) today announced that its Affirm ® Contrast Biopsy Software, which combines contrast-enhanced diagnostic ...

Stereotaxis gains CE Mark for MAGiC catheter, boosting revenue with high margins. FDA approval expected soon. Click here to ...

today announced it has filed for CE Mark registration for the Eversense® 365 CGM system. Eversense 365 is the world’s first and only one year CGM, which was approved by the United States (US ...

The Eversense 365 CE Mark submission was prepared in compliance with the EU Medical Device Regulation (MDR) and, upon approval, would enable the commercialization of Eversense 365 in European ...

With MDR CE Mark certification, clinics across Europe and other countries where the CE Mark is accepted, can now leverage these tools: AutoContour: Improves treatment planning by significantly ...

BSI Group will be the notified body for Modular Medical’s CE mark process, determining safety and efficacy of the device. The company believes it can obtain CE mark in the first quarter of 2026.

Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental ...

The Lynx pattern scanning laser indirect ophthalmoscope from Norlase received FDA clearance and a CE mark. The device allows surgeons to move freely during treatment. Lynx, Norlase’s pattern ...

The Magic ablation catheter. [Image courtesy of Stereotaxis] Stereotaxis (NYSE:STXS) said today that it has secured CE mark approval for its Magic robotically-navigated magnetic ablation catheter.