Welcome UFO. ARTH is on the right path. They are relying more on their third party to move things forward not just with the 510(k) but also the CE mark. The timeline is drawing closer to hear what the FDA says about clearing AC5. There has also been quite a bit of deregulation since March. This could get interesting very quickly. Looking forward to hearing more about AC5 progressing abroad.
CÚRAM is the Science Foundation Ireland Centre for Research in Medical Devices, based at NUI Galway. Supported by Science Foundation Ireland (SFI) and industry partners, CÚRAM enhances Ireland's standing as a major hub for the global medical devices industry. Its goal is to radically improve quality of life for patients with chronic illness by developing the next generation of smart, implantable medical devices. CÚRAM's innovative approach incorporates biomaterials, drug delivery, cell based technologies, glycosciences and device design to enhance, develop and validate both traditional and new combinational medical devices, from molecular design stage to implant manufacturing. CÚRAM's devices are being developed with strong clinical collaborations to enable rapid translation of research findings to clinical application. Key to the approach is the establishment of unique networks of national and international collaborations, integrating world class clinical, academic and industrial partners
Since Arch is relying on a third party a bit more patience is prudent imo.
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