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5 Responses

  1. Susan Sjölund
    Susan Sjölund March 11, 2014 at 6:28 am | | Reply

    Thank you for this amazing article, Amy! I am John’s wife (hugely pregnant with twin boys…and impatiently waiting for our miracles to arrive!) and Timesulin seems like our first ‘baby’…watching it spread its wings and fly across the Atlantic to the U.S. to help make life easier for people with diabetes over there is a dream that John and I have shared for a long time.

    Thank you for helping us make that dream reality!

    Susan (and boys-in-waiting)

  2. Shirley Riley
    Shirley Riley March 11, 2014 at 1:48 pm | | Reply

    This has been a great tool in the care of my type 2 elderly parent wit dementia.
    When in doubt about whether she has taken her insulin, we check the timer. This gives us assurance, but also helps us determine if maybe other health issues are developing when we have concerns about an infection and with verification of taking her insulin we can make better decisions about her care.

    I was able to purchase through an acquaintance I have in Britain and have it mailed to me. When I had a problem with the first pen you generously replaced it. Thank you!

  3. pwd doc
    pwd doc March 11, 2014 at 6:20 pm | | Reply

    I understand the FDA has a FREE process where you can come in, discuss your device with them, present your strategy for proving safety and effectiveness, ask questions, and get feedback BEFORE you spend any money on a submission. If you can’t come in person, you can arrange a teleconference.

    see http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf

  4. John Sjolund
    John Sjolund March 12, 2014 at 6:25 am | | Reply

    Hi PWD doc,

    The FDA has been very helpful and indeed provided us with guidance. Based on this information we have set the the path to getting approved in the FDA.

  5. pwd doc
    pwd doc March 12, 2014 at 11:05 pm | | Reply

    Great!

    Good luck!

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