Tandem t:slim gets FDA Approval

Tandem Diabetes Care, Inc. received U.S. Food and Drug Administration (FDA) approval on 11/16/11 to market the t:slim Insulin Delivery System. The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative. It has a revolutionary pump system powered by pressure with a microdosing mechanism that can deliver doses as small as 0.001 u. Unlike cartridge pumps that are connected directly to an infusion line, the t:slim has no motor and far fewer parts than current insulin pumps. It will also not overdeliver insulin (excess delivery can be as large as 1.0 to 1.4 units) during the pressure drops that occur in flight as the pressure drops inside an airplane after takeoff.

Tandem t:slim

Other exciting features of the t:slim include:

  • Small and discreet
  • Touch screen interface
  • Accurate insulin delivery with their Micro-delivery technology
  • Rechargeable battery
  • All pump settings on one page - no digging through menus to find the setting you want
  • Fast USB download to their online app, t:connect, for customizable reports
  • No airplane/gravity problems 

The pump cannot be purchased quite yet. Tandem will be running some small user trials to verify their manufacturing process before the pump is released. Expect to see the t:slim in the 2nd Quarter of 2012. We'll have more information on the pump on our site soon.

You can read the full press release here.

 

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