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.

    Dr. Michael Mina, the chief science officer for the at-home testing company eMed, said the FDA tends to have strict requirements for over-the-counter tests. The agency often asks manufacturers to conduct studies that demonstrate that people can administer at-home tests properly — a process that may cost millions of dollars and delay the test’s authorization by months or years, Mina said.

    “It’s taken a very long time in the past to get new self-tests authorized, like HIV tests or even pregnancy tests,” he said. “They’ve taken years and years and years and years. We have a pretty conservative regulatory approach.”

    Rapid tests for Covid, RSV and the flu are available in Europe. Why not in the U.S.?
    Aria Bendix | NBC News

  • 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)

    Dexcom shared Stelo’s name, and that the device had been submitted to the FDA for review in February. The sensor will be worn on the upper arm and lasts for up to 15 days before it needs to be replaced, according Dexcom.

    Jake Leach, chief operating officer at Dexcom, told CNBC in February that Stelo will have a unique platform and branding. The platform will be tailored to the needs of these Type 2 patients, he said, which means it will not include many of the alerts and notifications meant for diabetes patients at risk of experiencing more serious emergencies.

    “It’s designed to be a simpler experience,” Leach said in an interview. “There’s a lot of people who could benefit.”

    Dexcom’s first-ever over-the-counter glucose monitor patch gets FDA clearance
    Ashley Capoot | CNBC