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The Mountain View, CA-based company isn’t out of diabetes completely, as it still has partnerships in the space with DexCom, Sensile, and Sanofi.
Users can get a trial run of the neuromodulation therapy before having the Proclaim DRG system implanted.
Artificial intelligence–powered software prioritizes the assessment of computed tomography cases that may have indications of brain bleed.
One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), industry experts continue to express concern that more progress is needed to help companies prepare for the new regulations within the limited transition period.
News of Edwards Lifesciences' CE mark for Sapien 3 Ultra was dampened by Boston Scientific's preliminary injunction on the device in Germany.
The Galway, Ireland-based company is now aimed at gaining FDA approval, but Teleflex is looking to enter the U.S. market and Abbott Laboratories has leading share in the space.
The Irvine, CA-based company estimates it could get a PMA for its rechargeable sacral neuromodulation to treat urinary dysfunction and fecal dysfunction sometime in 2019.
The recall was prompted by an incident in which the top detector of a Millennium Nuclear Medical System detached and fell onto the detector below.
The spotlight will be on digital health products at the upcoming BIOMEDevice San Jose show. Hear now from one company making an impact.