• Why Omnipod 5, Dexcom G7 CGM, Freestyle Libre 3 CGM approvals taking so

    From _@21:1/5 to All on Sun Aug 8 11:20:53 2021
    The following, it blames Covid-19 (July 16
    2021): https://www.medtechdive.com/news/dexcom-wins-fda-nod-for-real-time-apis-allowing-third-party-developers-acc/603470/

    [clarifying inserts, not part of original
    article, included in brackets]

    Key Excerpts:

    ... slower FDA reviews have delayed certain
    product launches, such as the much-antici-
    pated Insulet Omnipod 5 insulin pump.

    The FDA's workload soared during the pan-
    demic as coronavirus-related applications
    seeking review or emergency use authoriza-
    tion came in.

    The agency was also managing its typical,
    non-COVID-19-related submissions, which
    were delayed due to the prioritization of pan-
    demic work.

    While the agency has been stretched thin,
    work may return to normal soon ...

    [The explosion in Covid-19 cases since the
    Delta Variant started escalating new cases
    the 2nd week in July, doesn't bode well for
    approval of the devices mentioned in the
    title of this post]

    ... the agency plans to return to normalcy be-
    ginning next year, according to a report ...
    "Goal is to be back to normal as we roll into
    2022." [see Delta variant, new U.S. cases 7
    day average now over 125,000, may go above
    previous high of 250,000 within one month]

    ... Abbott Laboratories ... is rolling out a new
    device of its own, the FreeStyle Libre 3. The
    CGM system received CE mark in September
    2020 and is available in Europe, but Abbott has
    not provided any timeline for a U.S. launch.

    - - -

    Possibility for Delta Variant explosion in U.S.:

    Though unexplained how this reversal occurred,
    therefore unknown if it will transpire the same
    way in the U.S., Delta variant Covid explosions
    in Britain & India reversed after about 2 months,
    so if that happens in the U.S., new cases would
    reverse about the 2nd week in September 2021.

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    Diabetes Bubble / Diabetes Bubble Burst https://prohuman.net/diabetesbubblediabetesbubbleburst.htm

    C.ure I.nsulinitis A.ssociation https://prohuman.net/cureinsulinitisassociation.htm

    Glucose Anomalies Research regarding
    Potential Cures / Improvements in Treatments https://prohuman.net/glucoseanomaliesresearch.htm
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