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CE Mark

Latest Headlines

Latest Headlines

Mitralign grabs $35M Series D cash to advance mitral valve repair device

Cardiac device company Mitralign attracted $35 million in new Series D financing. The Tewksbury, MA, company plans to use the investment infusion with its eyes toward European testing and commercial launch for its catheter-based mitral valve repair system.

Abiomed snags CE mark for Impella cVAD heart pump

Abiomed ($ABMD) is gearing up for a full European commercial launch of its Impella cVAD heart pump by this summer, now that it has obtained a CE mark for the device.

Medtronic scores CE Mark for MRI-friendly pacemaker lead

Medtronic ( $MDT ) has launched its CapSure Sense MRI SureScan pacing leads internationally after securing CE Mark approval. The leads are approved for use during MRI procedures. And this is very good news, as MRI procedures are indicated for 17% of pacemaker patients within 12 months of device implant, according to a company statement.

Koning gets CE Mark for breast CT system

West Henrietta, NY-based Koning has obtained CE Mark approval for its breast CT system. The system is the first commercially available, fully integrated breast CT scanner designed specifically to...

BD gets CE Mark for MRSA assay

On Thanksgiving Day, BD Diagnostics announced it had received CE Mark approval for the BD MAX MRSA assay, which is designed to rapidly and accurately identify methicillin-resistant Staphylococcus

Neovasc gets CE Mark for Reducer

Vancouver-based Neovasc ($NVC) has received CE Mark designation for its Reducer product for the treatment of refractory angina. The Reducer can be implanted quickly in a minimally invasive procedure