European medtech regulators approved Covidien’s (NYSE:COV) Nellcor Respiration Rate patient monitoring system, which captures oxygen saturation and pulse and respiration rates all through a single finger sensor.
CE Mark
Diabetes: Medtronic wins CE Mark for MiniMed Duo
Medtronic lands E.U. approval for NC Euphora coronary balloon
Press Release: Medtronic Announces CE Mark and Launch of NC Euphora Coronary Balloon
Press Release: Elixir Medical Receives CE Mark Approval for the Breakthrough Fully Bioresorbable DESolve 100 Novolimus Eluting Coronary Scaffold System
Elixir Medical touts E.U. win for disappearing DESolve 100 stent
California stent-maker Elixir Medical won approval from European regulators for its next-generation DESolve 100 fully resorbable coronary scaffold.
Acutus lands European approval for heart-mapping ‘Katheter’
European regulators approved Acutus Medical’s flagship ‘Katheter’ device, a diagnostic catheter for real-time 3D imaging and mapping of the heart.
The Katheter is just a part of Acutus Medical’s larger stand-alone system, the company said. The device contains 48 ultrasound crystals and electrodes that capture both the geometry of the heart and its electrical activity.
Medtronic wins CE Mark for Evera MRI SureScan ICD
Medtronic (NYSE:MDT) said it won CE Mark approval in the European Union for the world’s 1st market-cleared implantable cardiac defibrillator that’s safe for full-body magnetic resonance imaging scans, its Evera MRI SureScan ICD.
The Evera device is slated for an immediate launch in Europe, according to a press release.
Boston Scientific lands U.S., E.U. nods for Expect Slimline needle
Medtech titan Boston Scientific (NYSE:BSX) touted regulatory wins in the U.S. and the European Union for the Expect Slimline needle, designed to help biopsy tissue from organs near the gastrointestinal tract.
Abiomed wins CE Mark for Impella RP heart pump
Edwards Lifesciences lands E.U. approval for INTUITY Elite aortic valve
Edwards Lifesciences (NYSE:EW) announced today that it won CE Mark approval in the European Union to market its next-generation INTUITY Elite aortic valve.