Today, I’m cleaning out my inbox. You’re welcome.
In no particular order:
- Nipro Diagnostics TRUE METRIX™ and TRUE METRIX™ PRO have been approved by the FDA. So what, you ask? Another meter on the market. Whoooppeee.
But here’s the interesting tidbit:
“…the clinical data demonstrated that the two meter systems exceeded the minimum accuracy criteria for the new, more stringent ISO 15197:2013 performance requirements for accuracy.”
You know how I feel about blood glucose meter accuracy. We need it. Better accuracy from our blood glucose meters, better accuracy for our CGM readings, better dosing and food choice decisions = better days.
This is from a company that offers relatively inexpensive meter and strips. The devices will be on shelves by Q4 of 2014.
- Close Concerns/diaTribe has it going on all over the place. I
strongly encouragedemand that you take a moment to check the following out:
Kelly Close, the woman I swear never sleeps because she’s so busy doing amazing things for the diabetes community, presented this at a recent FDA meeting a few weeks back. (Click on this link to get her insightful slide presentation… so worth going through… it totally surprised me, and I’m pretty jaded these days.)
And then, there’s the work that DiaTribe is doing for #dstigma (diabetes stigma). Those of us who live with diabetes have probably felt unreasonably stigmatized at some point, whether it’s with friends, colleagues, strangers… and they’re showing this to the public in hard numbers. They did a study, and here are the results… and I love the fact that they’re not just satisfied with dumping the results on our lap. We’ve got work to do, people.
- ACCU-CHEK® Aviva Expert meter is the bomb for individuals using MDI therapy with a built-in insulin calculator.
I got to see this in action at the AADE conference in Orlando and was blown away. While I use a pump that does the calculations for me, if I didn’t, this would be the meter I use. Imagine not having to do the math when you want to inject:
“If my blood sugar is 196 and my target is 100 and I’m going to have 48 grams of carbohydrates but I took a correction bolus an hour ago so I’ve got insulin on board….how much insulin should I take?”
It’s easier to ask what time the train will arrive. The answer may be just as elusive. But this meter will do it (but don’t ask what time the train will arrive).
It’s not available off the shelf - you will need to ask your medical team to get you one, but if you’re on MDI… whoa. Get one of those in your hot little hands.
- National Medical Device Curriculum - Stop whining about how complicated the FDA makes the process of getting a device approved and start figuring out why. (Look, I used to whine. Not anymore.)
What is it? It’s a learning pathway for anyone who wants to know what it takes to get a medical device approved by the FDA, starting from scratch.
The National Medical Device Curriculum is a series of fictional case studies designed to help academic institutions and science and technology innovators understand FDA’s medical device regulatory processes. The FDA believes that better understanding of regulatory processes will accelerate the delivery of innovative medical devices to patients.
Regulatory pathways, PMA, 510(k), acceptable risk… it’s all covered with case studies. So worth your time if you are using ANY medical device to manage your diabetes.
Take a gander. Bookmark it. Share it. Discuss it. The more educated we get as a community about what the FDA does, the more we can help the FDA and device manufacturers with the process.
Thank you for helping to clear out my inbox. I feel so much better now. Do you do windows, too?