Thirdwayv Applauds Insulet’s FDA Clearance for the World’s First Tubeless Automated Insulin System with Smartphone Control
Congratulations to Insulet and all the kids who will sleep better now after the company announced FDA clearance of its Omnipod® 5 Automated Insulin Delivery System for people with type 1 diabetes aged 6 years and older. It is the first and only tubeless automated insulin delivery (AID) system in the US with compatible smartphone control and Dexcom® G6 Continuous Glucose Monitor (CGM) System integration to help protect against highs and lows.
In May 2019, we announced how delighted we were to be selected by Insulet as one of their trusted partners to help connect and protect its Omnipod DASH System that had been cleared by the FDA in June 2018. We knew then that the commercial deployment of our technology in such a mission-critical application was an essential step in providing the greater medical device industry with the most comprehensive smartphone-centric connectivity solutions available. Since that time, Insulet’s commitment to continuous innovation and the January 28, 2022, clearance of Omnipod 5 will further enhance the lives of not only adult patients, but also children who suffer from type 1 diabetes. Sleep well, little Johnny, sleep well!
Countdown to Safer Medical Devices
A six-month clock started ticking late last year, counting down to the FDA’s new deadline for updating its public-facing guidance for improving the cybersecurity of medical devices. This requirement became law on Dec. 29, 2022, as part of a $1.7 trillion Omnibus Appropriations Bill that also includes new rules for submitting applicable medical devices to…
Getting Real about Real-Time Location Systems
Real-Time Location Systems, or RTLS, emerged in the 1990s for use by government and military entities. The technology has been adopted in manufacturing, logistics and aerospace applications for years. Now it is coming into its own in a growing variety of other applications, from healthcare consignment inventory management to retail item tracking. It’s time to…
The Hidden Crisis Within Today’s Healthcare Crisis
The Healthcare Crisis of today – or, perhaps more accurately, over the past two years — has been never-ending waves of COVID-19 variants. With “Alpha” starting in 2019 to the current “Omicron” & “BA.2” mutations, our hospital systems have been stretched to the breaking point. This crisis has forced administrators to deal with huge patient…