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CE Mark certification

Latest Headlines

Latest Headlines

Europe's substandard breast implants may signal bigger regulatory problem

The scandal rocking Europe over substandard breast implants is heating up. And flaws in the EU's regulatory system may point to a looming crisis with other implantable devices. Let's start with the

AirStrip scores regulatory win in EU

AirStrip Technologies has won CE Mark certification for its mobile patient monitoring applications. The San Antonio-based company develops mobile software apps that work across most platforms and

IntraPace gets CE Mark for new abiliti lead

Mountain View, CA-based IntraPace has received the CE Mark for the LGL102, a new gastric stimulation/food sensing lead designed to work with the implantable abiliti system to reduce procedure time.

Cellnovo gets CE Mark for first mobile diabetes system

Cellnovo has received CE Mark approval for the world's first mobile diabetes management system ( photo ), which includes an insulin patch pump, a wireless, touch screen handset with a built-in blood

Quidel gets CE mark for influenza assay

Quidel ($QDEL) has received the CE mark for its first molecular diagnostic test, the Influenza A+B real-time RT-PCR assay. The CE mark allows for the launch of the open box molecular platform in

Mazor gets good news in Europe on SpineAssist

Israel's Mazor Robotics has received EU CE Mark certification for its SpineAssist miniature robotic for brain surgery. The company now plans to use the SpineAssist for brain surgery in Israel and