Insulet’s Omnipod® DASH™ Insulin Management System Receives FDA 510(k) Clearance

BILLERICA, Mass.–(BUSINESS WIRE)–Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced FDA 510(k) clearance of the Omnipod DASHTM Insulin Management System (Omnipod DASH). This clearance lays the foundation for a steady cadence of innovation that furthers Insulet’s mission to empower users to enjoy simplicity, freedom, and healthier lives with their differentiated technology.

“Our number one priority is to continue to minimize the daily strain on those impacted by diabetes and we are confident this system, and eliminating the system’s upfront cost, do just that.”

Tweet this
“Omnipod DASH was inspired by Podders and embodies what users on multiple daily injections have been asking for in a diabetes management system,” said Patrick Sullivan, Chairman and Chief Executive Officer. “Our number one priority is to continue to minimize the daily strain on those impacted by diabetes and we are confident this system, and eliminating the system’s upfront cost, do just that.”

Omnipod DASH was built to be simple, discreet and easy-to-use. The system features Bluetooth wireless technology for connectivity between the color touch-screen Personal Diabetes Manager (PDM), tubeless waterproof pump (Pod), and is optimized for use with the CONTOUR® NEXT ONE Blood Glucose (BG) Meter for the seamless transfer of blood glucose readings to the PDM’s bolus calculator. Bluetooth functionality also provides connectivity to the Omnipod DISPLAY™ and Omnipod VIEW™ apps. The DASH PDM will be offered at no cost with the purchase of Pods.

The Omnipod DISPLAY and Omnipod VIEW apps will provide users and their caregivers quick and easy access to their insulin therapy information on their smartphones. Omnipod DISPLAY allows users to discreetly monitor their PDM data on their smartphones along with other Podder-inspired features including “Find my PDM”. Omnipod VIEW allows parents and caregivers to monitor their loved ones’ diabetes more easily and with greater peace of mind. The iOS Today View widget allows users and their care teams to see their or their loved ones’ PDM and continuous glucose monitor (CGM) data on one smartphone screen with one swipe.

“I’m thrilled with the new Omnipod DASH System,” said Tessa Mellinger, a college student with Type 1 diabetes who was part of the DASH user testing and development. “The PDM display is easy to read, the steps to managing basal rates are user friendly, and the food library is really helpful. The fact that it looks like a smartphone makes it cool to carry and may help eliminate those awkward questions from strangers.”

Insulet would like to thank the Centers for Devices and Radiological Health (CDRH) branch of the FDA for its collaborative efforts, timely review and ultimate clearance of the Omnipod DASH Insulin Management System submission. Insulet looks forward to working with Captain Alan Stevens and his team as the Company continues to work on its robust innovation pipeline.

Submission for FDA 510(k) clearance of the Omnipod DASH was announced in January, and while today’s clearance allows Insulet to commercialize this product in the United States, the Company is taking a measured approach through a limited market launch to ensure an ideal user experience at full market release. Full market release is estimated to begin in early 2019 in the United States.

For more information on product details, availability and a comprehensive list of FAQs, please visit the Omnipod website.

1 The Pod has a waterproof IPX8 rating for up to 25 feet for 60 minutes. The PDM is not waterproof.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to making the lives of people with diabetes and other conditions easier through the use of its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod, by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across multiple therapeutic areas. Founded in 2000, more than 140,000 users across the globe rely on Insulet’s Omnipod Insulin Management System to bring simplicity and freedom to their lives. For more information, please visit:, and*

*Starting July 1, 2018, Insulet will assume direct distribution of its Omnipod Insulin Management System in Europe, including sales, marketing, training and customer support activities. This will allow Insulet to be closer to the diabetes community and identify opportunities to support European customer needs over the long-term, as it already does in the United States and Canada.

Forward-Looking Statement:

This press release may contain forward-looking statements concerning Insulet’s expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 22, 2018 in the section entitled “Risk Factors,” and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

1 Like

Wouldn’t it be nice if the price went down on the older pods? I’m not seeing any reason I would care to trade up…or purchase the new pods which is the trade up…But regardless, I love my new Omnipod system!

Hmmm. No mention of connectivity to Dexcom or any CGM. It has been a weak link of the Omnipod system since they promised it was coming when I starting pumping with it in 2009.

It’s been mentioned a lot by Omnipod, and is scheduled with the release of the Omnipod Horizon system in late 2019.

For those of us unbothered by the PDM, it’s not quite clear what advantage the Dash has. Its primary objective seems to be to get us used to using a phone in conjunction with our pump. Hello, Omnipod, we’re quite used to smartphones by now. But do we really want to carry around two?


This is obviously the one step backward before the two steps forward. No CGM and no built-in BG meter. :face_with_raised_eyebrow:

As far as whether the “two steps forward” will actually be two steps forward, who knows? It may be great for some, but I have doubts about turning over my insulin delivery to an algorithm built for the masses.

I started on Omnipod May 16. The trainer said many will not like giving up that built in meter. I plan to stick with the current system and see no big deal with this new one. Things are working well with my Libre and the pods but I sure do hope the prices drop so I can continue to afford them.
Here’s the best link for info:

I am totally underwhelmed by the Dash step. I see more negatives than positives until the Horizon system is introduced

1 Like

Definitely agree… I see ourselves with two smartphones held by a rubber band or some sort of diy invention…
Omnipod, is it so hard to make this silly locked up phone just an app to be installed in everybody’s phone???

No, it’s not hard at all for them to make an app that does that.

The hard part is getting the FDA to approve it.

1 Like

I think the phone app approach is coming, as patients will insist on it. This is just an interim step. I was excited about Dash for awhile, but the lack of a meter and having to recharge the PDM regularly rather than changing batteries (rechargeables) every six weeks or so, makes me less than enthusiastic about making a change at this point. Coordination with my Dexcom CGM could change my mind.

I may just be repeating what some of you had mentioned already, but I’ll say anyway.

I also don’t see what the improvement is, to a point.

I like the idea of the new PDM - like a phone - slim and nicer looking, but it would have been way, way better to have an all in one system, not two handhelds an one / two wearables.

As well as the whole charging thing, its a nice idea, but it is easier to just do the whole battery thing. Less worry in my mind too, I mean trying to find a power source would be a nightmare.

I don’t wear a CGM, so the whole communicating together an keeping me in line with BG is out the door, now if I read right, you can do all that without a CGM with the new, so when you test an sends it to the new PDM is does whatever, but then that’s exactly what I have now, just not Bluetooth. Lol.
I only say this because my doctor want’s me to go on a CGM, to then communicate to the pod, which would be linked to the PDM, but I honestly don’t want another deice on my body, an other reasons, but we won’t get into that.

I wouldn’t say no to caring two items to the one now, as they both aren’t too large and bulky, and I DO NOT hide that I am diabetic, but I naturally hate carrying things, so less = great.

To be honest I hope and pray they make a all in one whatever, like super soon, Pod will be insulin pump / CGM, and a meter / PDM, with the whole Bluetooth. I don’t think it would be that difficult to make but getting it approved and at a reasonable size for both items. I don’t think it can’t be done in the age we are living in, I just don’t think they care enough to make it.



This is a colossal mistake by Omnipod. It was bad enough that we had a 1980’s PDM, but at least it WORKED, and had a meter. Now were are going to be forced to carry a crippled cell phone, with S*&^%y battery life which we will have to charge daily. HUGE step backwards by Omnipod - but with their Pods being sent out for pain management and after Chemo treatment - I really think they just don’t care anymore. They have extended into other areas where the pods are meaningful, and the diabetics are left getting the scraps. As much as I love the Omnipod system, I will switch if I am forced to go this route. Take away their money, and it will force change. Shame on them. Anyone here who knows me knows that I am their biggest fan, until now.