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Insulet plans label expansion for Omnipod in type 2 diabetes

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Insulet is looking to expand the use of its tubeless insulin pump, Omnipod 5 automated insulin delivery system (Omnipod 5), in people with type 2 diabetes who require insulin.

Source
Clinical Trials Arena

Insulet Omnipod 5 iPhone App FDA Cleared

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Insulet claimed a big win for its Omipod 5 hybrid closed-loop system today with the news it’s received FDA 510(k) clearance for the device’s accompanying app for iPhone. Already available on Android, the iPhone app clearance makes the Omnipod 5 the only tubeless automated insulin delivery (AID) system with full control from a compatible smartphone, according to the company. This gives more options for patients who prefer not to carry the separate device controller with them.

Source
Medical Devices and Diagnostics Industry

Diabetes Tech: A Catalyst Rich Sector with a Dazzling Future

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Early last year, MD+DI predicted that 2022 would be the biggest year yet for diabetes tech – and we weren't wrong. If the latest news and analyst takeaways from the sector's biggest 2023 conference is any indication, however, we haven't seen anything yet.

Marie Thibault, a medtech analyst at BTIG, said overall attendance at the American Diabetes Association (ADA) 83rd Scientific Sessions seemed low compared to pre-COVID and other medical meetings she's attended this year. However, analyst and investor attendance at ADA was particularly high, she noted in a report Monday.

Source
Medical Devices and Diagnostics Industry

Insulet warns Omnipod 5 insulin pump charge issue may cause fire

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Insulet issued an urgent medical device correction on Wednesday for its Omnipod 5 insulin delivery system because of an issue with the charging port and cable.

Source
Medtech Dive

'Not for the faint of heart': Insulet CEO talks Tandem and Medtronic competition, Omnipod 5 launch

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Shacey Petrovic spoke to MedTech Dive about the long-awaited launch of its insulin pump, competitors' developing patch pumps and how the Ukraine crisis will impact the industry.

Source
Medtech Dive

Insulet Omnipod 5 insulin pump clearance delayed to 2022: CEO

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Insulet said it now expects FDA clearance for its much-anticipated Omnipod 5 insulin patch pump in the first quarter of 2022 rather than later this year, a delay that sent its stock tumbling more than 8% on Friday.

Source
Medtech Dive

10 of the Most Anticipated New Medical Devices

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The end of the year may be drawing near, but there are still plenty of medical devices pending regulatory approvals that could hit the market by year-end. The medical devices featured in this slideshow are among the most anticipated, but we note that COVID-19 workload at FDA could cause delays for some.

Source
Medical Devices and Diagnostics Industry

Insulet comes out fighting

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The grinding to a halt of a pivotal trial of a new technology is rarely a good sign. The insulin pump developer Insulet, however, not only managed to get the study of its Omnipod 5 artificial pancreas back up and running after addressing a software glitch, but has now posted highly competitive data in type 1 diabetes.

Source
EP Vantage