Rumor Has It…

I’ve had a few quite intriguing anonymous tips in the last few days.

No. 1: The updated, and much upgraded, version of MiniMed’s Guardian RT Vipversion2stamp continuous monitor is possibly approved — or a hair from approval — by the FDA. Apparently version 2.0 is “totally kick-ass,” sporting every feature you can think of and some you probably never would’ve dreamed of. Ready for nationwide roll-out by the end of this year?

If this is true, it’s looking like rather bad news for Abbott Diabetes, whose competitor CGM Navigator is still stuck at the starting gate with the FDA. My understanding is that Abbott made a misstep by submitting its technology as a replacement for traditional fingerstick glucose meters, which has made it much harder for the FDA to swallow, accuracy-wise.

No. 2: Several companies are working on “OmniPod copycats” — i.e. wireless insulin pumps that require the user to wear only a small pod (the insulin reservoir) attached to the body, which is managed by a separate, remote-controller unit that also doubles as your glucose meter. In short, OmniPod is the coolest thing to happen to insulin-dependent diabetics since the advent of the insulin pump itself. The company has won a host of design awards, so no wonder others are scrambling to create “me too” products. More good news for us!

No. 3: An unnamed company is also working on a new disposable insulin pump with two reservoirs. I said “intriguing,” didn’t I?

That’s all I know at the moment. But in case you like to follow pharma industry gossip, check out PharmaGossip. You won’t be sorry.

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4 Responses

  1. art-sweet
    art-sweet July 17, 2006 at 6:20 am | | Reply

    Any idea how this new version of the RT will relate to the 522/722? Is it a change in the sensor technology or in the monitor?

  2. Becky
    Becky July 17, 2006 at 6:44 am | | Reply

    Thanks for the update Amy. I just got the FDA PMA summary for June and the RT upgrade was in there.
    http://www.fda.gov/cdrh/pma/pmajun06.html

    Search for Guardian to read about the changes.

    As far as the Navigator goes, they have probably dropped seeking replacement approval. Take a look at all the job postings in Alameda. They are staffing up for something big. I’m thinking it’s the Navigator, maybe the Aviator, maybe both. They just started posting a bunch of marketing and legal jobs for Abbott Diabetes Care. Something’s up. Like I mentioned before, they are hiring 1 year contractors for the “next generation Navigator/Insulet caregiver monitor”. I don’t think they would hire contractors unless approval was imminent.

    Thanks for the link to the pharma rumors site! I hadn’t found that one. There is also http://www.cafepharma.com that has a message board with some very interesting posts in the endocrinology and medical devices areas.

  3. Insider
    Insider July 17, 2006 at 10:32 pm | | Reply

    Thanks for the hat tip.
    Have linked to you.
    Cheers
    Insider

  4. JasonJayhawk
    JasonJayhawk July 18, 2006 at 12:54 am | | Reply

    Ooooooo! I love “insider” information. Thanks to whatever bird whispered those items to Amy.

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