Tag: FDA

  • Why don’t we (still) have rapid viral diagnostics?

    One of the most disappointing outcomes in the US from the COVID pandemic was the rise of the antivaxxer / public health skeptic and the dramatic politicization of public health measures.

    But, not everything disappointing has stemmed from that. Our lack of cheap rapid tests for diseases like Flu and RSV is a sad reminder of our regulatory system failing to learn from the COVID crisis of the value of cheap, rapid in-home testing or adopting to the new reality that many Americans now know how to do such testing.

  • Dexcom non-prescription glucose monitor approved

    Cheap and accurate continuous glucose monitoring is a bit of a holy grail for consumer metabolic health as it allows people to understand how their diet and exercise impact their blood sugar levels, which can vary from person to person.

    It’s also a holy grail for diabetes care as making sure blood sugar levels are neither too high nor too low is critical for health (too low and you can pass out or risk seizure or coma; too high and you risk diabetic neuropathy, kidney disease, and cardiovascular problems). For Type I diabetics and severe Type II diabetics, it’s also vital for dosing insulin.

    Because insulin dosing needs to be done just right, I was always under the impression that one of two things would happen along the way to producing a cheap continuous glucose monitor, either:

    1. The FDA would be hesitant to approve a device that wasn’t highly accurate to avoid the risk of a consumer using the reading to mis-dose insulin OR
    2. The device makers (like Dexcom) would be hesitant to create an accurate enough glucose monitor that it might cannibalize their highly profitable prescription glucose monitoring business

    As a result, I was pleasantly surprised that Dexcom’s over-the-counter Stelo continuous glucose monitor was approved by the FDA. It remains to be seen what the price will be and what level of information the Stelo will share with the customer, but I view this as a positive development and (at least for now) tip my hat to both the FDA and Dexcom here.

    (Thanks to Erin Brodwin from Axios for sharing the news on X)