February 8, 2013

Bernard Spots a New Insulin Pump Approval in FDA Docs: the Pearl

OK we d-geeks can be like bird spotters looking for prey in the thickets. So props to my pal Bernard who spotted what sure looks like FDA clearance for the Asante Pearl, a new insulin pump in the wild of the FDA's latest round of 510(k) announcements. 510(k) means something is substantially equivalent to some other approved device and this claims to be the equivalent of and Animas 1200 IR or a Disetronic D-TRONplus.

A screen grab off Asante's site shows Pearl looks like this:

I don't know much about it but this is what the company web site says:

The Pearl insulin pump is designed to make living every day with an insulin pump, easier. 
Filling a pump reservoir is an outdated process in today’s world. So we designed our insulin pump around a pre-filled insulin cartridge, a simple-to-use interface, a pump that primes itself as you assemble it, and occlusion detection designed to identify occlusions earlier. Not just fancier, but really, less work. 
The Pearl insulin pump has a durable controller and a replaceable pump body that, once assembled, functions as a "traditional" insulin pump. Just insert the prefilled cartridge into the replaceable pump body that simply clicks together with the controller, and off you go.
Half the work, half the time.

OK. There ya go.

Reservoirs are not on the top of my list of pump issues but Your Diabetes May Vary. I left a message for a PR guy and will pass on what I learn.

Kudos to Bernard for spotting the FDA announcement. 


  1. We wrote about the Asante pump in early January. The Pearl was approved in May 2011 by the FDA. They've been working and prepping for launch behind the scenes, and this was an improvement/upate-focused FDA approval. Company plans to have it to market by mid-2013.

  2. A little "meh" for me. Prefilled cartridges by whom? What analogues will be offered? I'm looking for a pump that is smaller (or if not smaller, dual cartridge with glucagon) with the ability to collect and analyze data easily. Not seeing that from what's there so far, but you know... I could be wrong.