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!
We’ve gotten word that the FDA has approved the exciting Dexcom SHARE system, the first mobile device approval of its kind that allows data from a continuous glucose monitor to be beamed via Bluetooth wireless technology to as many as five smartphones anywhere!
The San Diego-based CGM company Dexcom announced on Monday that it had received FDA approval, 15 months after submitting the device for review in July 2013.
Yes, it’s SHARE with all caps……
Huge news, D-Friends: the new rapid-acting inhalable insulin known as Afrezza has just obtained FDA approval!
The third time’s the charm for this new formulation of inhalable insulin, the second-ever to make it through the U.S. regulatory process after Pfizer’s failed Exubera the better part of a decade ago.
On Friday, the California biotech company MannKind Corp. finally obtained regulatory clearance for its Afrezza device. Twice before, regulators turned down Afrezza asking for more clinical…
OK, take a deep breath, Diabetes Friends.
Go on: Inhale, Exhale, Inhale, Exhale.
You know why — there may soon be a new type of insulin on the market, the second attempt at a viable inhaled insulin since Pfizer’s Exubera product fizzled seven years ago.
On April 1, an FDA advisory panel gave a thumbs up to MannKind Corp.’s inhaled insulin Afrezza, which would be used specifically for meal-time doses to prevent post-prandial blood sugar…
There’s a lot of fuss and excitement about the newest diabetes device approved for people in the U.S.: Medtronic’s long-awaited 530G system and Enlite sensor… But at the same time, there’s a significant amount of frustration by PWDs (people with diabetes) and others in the know who feel they’re being misled on a number of fronts about this new device.
I’m one of them.
Let me preface this by saying: Many are very excited about…