Therma Bright Inc V.THRM

RE:FDA APPROVES BreathTest.

[Watchman21]

OH MY GOD! THE SKY IS FALLING, CHICKEN LITTLE...

This is a massive size. (Small Carryon Suitcase), expensive breathalyzer device that will produce 100 per month for point-of-care only (and might require someone to clamp the bridge of their nose with a clothespin to get proper air volume and force).

Do people really think this is gonna steal the testing market from a simple $5-$6 rapid antigen saliva test? If so... THEN OH MY GOD...SELL SELL SELL. LOL.

Now, that makes me laugh.! Watch the bashers on this site go wild over this. Just watch.

Check out this device's IFU (Information for Users: https://www.fda.gov/media/157723/download). Their cross reactivity studies were throat lozenges, sprays, robitussin syrup, etc... What about all the mouth-borne viruses & bacteria that THMR had to test against? Surely everyone knows that Covid19 is carried through small microscopic droplets from a person's mouth (via breathing, coughing or even kissing) or nose (via sneezing). Why isn't there a list of these mouth-borne viruses/bacteria that were tested, viruses/bacteria like gingivitis, etc???

I'll tell you one plausible reason, some other FDA team evaluated this device, separate from the Lateral Flow Device Team that THRM's device is evaluated by, and these teams probably sit next to each other, but don't chat and share ideas in their offices in Rockville, Maryland up by NIH/Bethesda Campus. LOL.

Anyway, NO WORRIES! THRM did all that the FDA requested around the mouth-borne viruses/bacteria and passed... All is still good and positive...Its just interesting on how this list of mouth-borne viruses we're not part of this device's study. Inconsistent? In my OPINION...YES.