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Insulet Gets FDA Clearance for Omnipod 5 Automated Insulin Delivery System

It's the first tubeless system with smartphone control.

Image source: Insulet

Insulet (PODD) announced Friday that it has received FDA clearance for its Omnipod 5 Automated Insulin Delivery System for people aged six years and older who have type 1 diabetes.

Omnipod 5 is the first tubeless automated insulin delivery system that integrates with the popular DexCom (DXCM) G6 Continuous Glucose Monitoring (CGM) System and a smartphone to enable users to automatically adjust insulin levels.

Shacey Petrovic, Insulet President and CEO, said, "Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes."

Omnipod 5

Insulet's newly approved system consists of a tubeless pod that adheres to a user's body. The pod is equipped with the company's proprietary SmartAdjust technology that communicates with the DexCom G6 CGM and the Omnipod 5 mobile app. Users can alternatively use the Omnipod 5 controller instead of the smartphone app. 

SmartAdjust receives a DexCom CGM value and trend every five minutes. The system then predicts where glucose levels will be an hour in the future 60 minutes into the future and adjusts insulin delivery accordingly 

Kevin Sayer, Chairman, President and CEO of DexCom, said, "As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system.”

FDA Clearance May Support the Stock

Image source: BigCharts

Insulet stock has tumbled 40% since peaking at $324.81 on November 10, 2021. We think the FDA's clearance of Omnipod 5 is just what investors needed to feel positive about prospects again.

The ability for users to manage their own glucose levels with no multiple daily injections, no tubes and no fingersticks, and all through the convenience of their smartphones, will be welcome news.

We think the recent selloff has been overdone and expect to see the stock move higher on the news.

The company is due to report Q4 and full year earnings after the close on February 23, 2022, and has promised to discuss the Omnipod 5 in greater detail on the earnings call.


Source: Equities News

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