FDA clears Freestyle test strips for use with OmniPod

 

"The FDA has notified the company that the new Abbott Freestyle test strip has been cleared for use with the OmniPod," Insulet confirmed in an email to MassDevice. "The companies are in the midst of updating the product label and will be communicating with customers once that has been completed, hopefully next week."

It's official, after more then a year and I can only imagine how much cost to taxpayers, the FDA finally has said that we can use Abbott's butterfly test strips in our OmniPod PDMs.

I'm not all that excited and am about to be a bit snarky about this announcement because I figured this out over a year ago for free and it only took me two days.

I completely understand and support that medical devices, equipment and the like need to be safe, accurate and durable but come on - test strips? I asked myself last year, "why would Abbott develop and manufacture a test strip that wouldn't work with their business partner's testing devices". I found the common sense answer to simply be, "of course they wouldn't do that". Then I conducted my own test and began using the strips with Arden's PDM in December of 2010, we have never looked back.

I'd like to congratulate the FDA on once again turning something simple into a train wreck, you guys are nothing if not consistent. Maybe now they'll (FDA) have time to clear Insulet's latest OmniPod design, from what I understand it's being held up because the "documentation can be confusing". To be clear, I've seen the documentation, used the new pods and not only couldn't the documentation be any simpler but it's about 99% the same as the current generation's instructions. In my opinion the new OmniPod design is being held up because of bureaucratic and political BS.

Our representatives in D.C. love to say that business should allowed to thrive but they'll take any chance to stand in it's way. Insulet is not a huge or rich company. They make a wonderful product that every day helps countless people live easier and more healthy lives. I'd very much like to see the FDA give them a chance to make a profit so that their amazing insulin pump can be around until type I diabetes is cured. Hopefully that cure, when discovered, won't be held up by the FDA forever...

I assume that most of you, because of necessity, have already implemented the "new" strips but just in case you were waiting for official word, you can find it here it's entirety.

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Update on Thursday, January 12, 2012 at 10:38AM by Scott Benner

Insulet has posted a link to updated information.

Diabetes Tech News: Medtronic Launches First-Of-Its-Kind mySentry™ Remote Glucose Monitor

Medtronic announces mySentry and I rejoice. Their new innovation does sound familiar...

mySentry Allows Caregivers to See Real-Time Insulin Pump Information and Glucose Trends from Another Room

MINNEAPOLIS – January 4, 2012 – Today, Medtronic, Inc. (NYSE:MDT) announced U.S. Food and Drug Administration (FDA) approval and U.S. market launch of the first-of-its-kind mySentry™ Remote Glucose Monitor, which allows a parent or caregiver to monitor from another room a patient’s MiniMed Paradigm® REAL-Time Revel™ System. The remote glucose monitor also marks the launch of a new category of Connected Care solutions that will provide people with diabetes and their caregivers convenient options to access their diabetes management information.

Perhaps more then any other chronic dieses, management of day-to-day diabetes lends itself to cutting edge technology. While I'm always grateful for the advancements that have already been made, I'd like to see more and see it faster. 

Even if you don't use a Medtronic device (Arden uses a DexCom CGM) this news is fantastic. Wireless technology like this is sorely needed and Medtronic's announcement will serve us all well, spurning other manufacturers to move forward as quickly as possible so not to be left behind. It is also a signal to other companies that the FDA is allowing clearance for technology such as this. That knowledge will make it easier for smaller companies to get into the game. Many device manufacturers are smaller and less profitable then you may imagine and they can't afford to get trapped into a protracted submission process with the government.

I love the FDA saying yes, I love Medtronic trying and I look forward to finding out what is next - please just don't price us all out of when your products come to market.

Medtronic's complete press release is at this link.

ps. It's time to let Insulet give us their smaller pods FDA - I mean really... which ever device lobbyist has you holding this up (my supposition)... they've gotten their monies worth, time to think about the people again.

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Will meters get better

GAITHERSBURG, Maryland (Reuters) - U.S. health regulators are taking a closer look at how well devices used by diabetics to monitor their blood sugars work, seeking possible changes for device makers to help make them more reliable.

At a two-day meeting to review blood glucose meters, Food and Drug Administration officials and staff pointed to a number of issues that can prevent people from getting proper treatment and sought input from medical experts and industry on ways to improve test results with the widely used devices.

The FDA gets about 12,000 reports of errors with such meters each year and is currently weighing new industry guidelines, said Jeffrey Shuren, director of the agency's Center for Devices and Radiological Health.

The rest of the story is here:http://us.mobile.reuters.com/mobile/m/AnyArticle/p.rdt?URL=http://www.reuters.com/article/idUSTRE62F5HV20100316