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.
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.
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.
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.
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.
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.
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.
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.