Asante’s New Insulin Pump Receives FDA 510(k) Clearance

Shares

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Asante Solutions’ Pearl Insulin Pump. The pump has also received the CE Mark, a European proof of conformity that certifies the product meets EU safety, health and environmental requirements.
 
According to the company’s press release, the Pearl insulin pump is the first fully-programmable insulin pump cleared under the FDA’s new more comprehensive and stringent infusion pump guidelines. The pump features a unique modular product configuration that allows significantly lower pump therapy initiation costs through pay-as-you-pump pricing. It is the only insulin pump using glass pre-filled 300 unit insulin cartridges for use in pumps for up to seven days.

1
Leave a Reply

avatar
3000
1 Comment threads
0 Thread replies
0 Followers
 
Most reacted comment
Hottest comment thread
1 Comment authors
Melissa Willey-Crystle Recent comment authors
  Subscribe  
newest oldest most voted
Notify of
Melissa Willey-Crystle
Melissa Willey-Crystle

THIS IS SHARP LOOKING!  i WANT TO GET ONE AS A TRIAL USE AND SEE HOW IT WORKS….

Copyright © 2009-2018 Diabetes Media Foundation, All Rights Reserved.
ASweetLife™ is a trademark of the Diabetes Media Foundation, All Rights Reserved.