The FDA has posted a notice that an Insulet recall related to Omnipod Dash batteries is Class I, its most serious level. Insulet recently issued a voluntary global safety notice to warn about battery problems. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. The […]
Insulet
Insulet issues device correction on Omnipod 5 controller due to charging issue
Insulet (Nasdaq:PODD) announced a medical device correction for its Omnipod 5 automated insulin delivery system. Acton, Massachusetts-based Insulet’s correction relates to an issue with the Omnipod 5 controller’s charging port and cable. The correction does not impact the Omnipod 5 pod, the previous-generation Omnipod Dash and Omnipod, or compatible Android smartphone devices with the Omnipod 5 […]
Insulet warns of battery issues with some Omnipod Dash PDM devices
Insulet (Nasdaq:PODD) recently issued a voluntary global safety notice to warn of battery problems with its Omnipod Dash system. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. Insulet’s notice went out to current and past users of the Omnipod Dash […]
Insulet stock rises on Street-beating Q3, raised sales guidance
Insulet (Nasdaq:PODD) shares ticked up after hours today on third-quarter results that came in ahead of the consensus forecast. Shares of PODD rose 8.1% at $276 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day down 3.8%. The Acton, […]
Here’s what diabetes tech companies are doing for National Diabetes Awareness Month
As we enter November, we enter National Diabetes Awareness Month. A number of diabetes technology developers plan to mark that in a special way. Dexcom (Nasdaq:DXCM), Insulet (Nasdaq:PODD) and Embecta (Nasdaq:EMBC) all announced their plans to celebrate. Last year, a handful of companies marked the month — which includes World Diabetes Day (Nov. 14) — […]
Insulet CEO Jim Hollingshead talks leadership in a time of change
Insulet (Nasdaq:PODD) CEO Jim Hollingshead says his current field in some ways marks his third different career path. He began as an academic, then went into consulting. The former ResMed executive took over in the corner office at Insulet following CEO Shacey Petrovic’s departure for personal reasons earlier this year. He’s served on Insulet’s board since […]
Insulet wins CE Mark for Omnipod 5 for children 2 and up
Insulet (Nasdaq:PODD) announced today that it received CE mark approval in Europe for its Omnipod 5 automated insulin delivery system. Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts-based Insulet said it represents the first CE-marked tubeless hybrid closed loop system. The latest-generation Omnipod 5 […]
FDA clears Insulet Omnipod 5 for children two years and older
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes. Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older. In June, […]
Insulet up on Q2 sales beat, raised full-year guidance
Insulet (Nasdaq:PODD) stock is up today — a day after releasing Q2 results that blew past the consensus revenue forecast. The Acton, Massachusetts–based automated insulin delivery technology developer yesterday evening posted losses of $35 million, or 50¢ per share, on sales of $299.4 million for the three months ended June 30, 2022, for a $10 […]
Insulet begins full market launch for Omnipod 5
Insulet (Nasdaq:PODD) announced today that it commenced the full market launch for its next-generation Omnipod 5 system. The Omnipod 5 automated insulin delivery (AID) system has now been made fully available through U.S. retail pharmacy channels for individuals aged six years and older with type 1 diabetes. Acton, Massachusetts-based Insulet received FDA clearance for Omnipod […]
