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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