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Novadaq Technologies Inc. Message Board

  • ironyworks ironyworks Jul 23, 2014 5:54 PM Flag

    ISRG effect

    Somehow the 17% rise in ISRG didn't have a proportionate effect here as it's decline did. Sniff.
    I live on a cliff and i we say, hey, going down's easy!

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    • andersongordon

      You usually listen to the ISRG conference calls. Any mention of FDA approval for our equipment in the DaVinci?
      regards endo

      • 1 Reply to e11ndofwar
      • Endo - The only mentions in the CC were that FDA clearance is still in process for the da Vinci Xi version of Firefly:

        "Turning to new products, we’ve received FDA clearance for our Xi Vessel Sealer and are working through the clearance process with Xi Stapler and Xi Firefly in United States and other countries. These advanced technologies are an important step in filling in the Xi offering. Our Xi architecture simplifies implementation and improves performance for our advanced instruments, and we look forward to their introduction around the world. We have submitted our 510-K application for our single-site wristed needle drivers, and are working through the clearance process. Pilot product performance for the wristed needle driver for single-site is compelling. We expect it will add significant capability and efficiencies for single-site surgeons."

        And also... "We are currently in the process of obtaining US FDA and international regulatory clearances for the Xi versions of our Stapler and Firefly products"

        So we still have no idea when US FDA approval will come - best case is this quarter based on 90-day FDA cycle. Also, will the Xi version of Firefly include the newer Spy/Pinpoint capabilities? If so does this imply a re-negotiated deal with NVDQ?


        Sentiment: Buy

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