It’s finally here!
A whopping 19 months after being sent in for regulatory review, JnJ’s new integrated Animas Vibe insulin pump + continuous glucose monitor has gotten the green light from the FDA to be sold in the United States! (See also: it finally got some ‘good vibes’ from regulators )
Word came early Monday morning in the form a press announcement that on Nov. 25, the FDA had finally OK’d the Animas Vibe —…
It’s finally here!
As you may know, our correspondent Wil Dubois was on the ground in Orlando, FL, covering the big annual American Association of Diabetes Educators (AADE) meeting for us last week.
Check out his first Newsflash on Asante and Insulet stuff from last Friday. And now, we bring you his full report of product news from the trade show floor…
It must have been the heat and humidity. After all, AADE chose to host their annual…Read more »
You may remember the big headlines two years ago when PWD tech expert Jay Radcliffe gave a presentation at a hacker’s conference detailing what he perceived to be a real cybersecurity threat for medical devices. The media gobbled up the juicy story about he was able to tamper with his own Medtronic insulin pump — though most level heads within the Diabetes Community saw this as mostly a publicity stunt and not a practical concern,…Read more »
When exactly the Animas Vibe integrated insulin pump and continuous glucose monitor (CGM) hits the U.S. market is now up to the FDA.
Almost two years after the Animas Vibe got OK’d for sale in Europe, this Monday Johnson & Johnson submitted the pump to the U.S. regulatory agency. The company publicly announced the submission during their first quarter earnings call early this morning.
Our Diabetes Community has been anxiously awaiting this news since October,…
Snuggled up in my bed under the warm covers, all I want to do is keep my eyes closed.
But, no. My darn insulin pump and continuous glucose monitor (CGM) just won’t shut up and let me sleep. Both vibrate and beep incessantly, reminding me that I’m low and nagging me to wake up and do something about it.
Neither device can actually intervene or do anything to prevent these lows (or highs) from happening.…