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Tandem Diabetes Wins FDA's iAGC Designation for Basal-IQ

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Tandem Diabetes Care, Inc. TNDM recently received the FDA approval for its Basal-IQ technology to be used as an interoperable automated glycemic controller (iAGC). Earlier in December, the company, for the first time, received the iAGC designation for its t:slim X2 insulin pump with Control-IQ technology following the FDA approval.

Going by FDA’s classification, there are three categories based on the interoperability of an insulin pump device as a complete automated insulin dosing (AID) system. These are an alternate controller-enabled insulin pump (ACE pump), an integrated continuous glucose monitor (iCGM) and an iAGC. While Basal-IQ technology gets the iAGC designation, the t:slim X2 insulin pump was the first to receive an ACE infusion pump classification last February. In June 2018, this was the first insulin pump being designated to be compatible with iCGM devices.

The latest regulatory clearance is expected to boost Tandem Diabetes’ global pump shipments and expand its customer base.

More About Basal-IQ Technology

Tandem Diabetes’ t:slim X2 insulin pump with Basal-IQ technology uses a predictive low-glucose suspend algorithm which utilizes sensor values from an integrated Dexcom G6 continuous glucose monitor to help lessen the frequency and duration of low-glucose events (hypoglycemia).

 

One major advantage of the Basal-IQ technology is efficiency in forecasting and preventing low-glucose events, as well as no requirement of finger sticks or complicated settings.

One of the unique features of the t:slim X2 insulin pump is that it has greater insulin holding capacity despite being smaller in structure.

Market Prospects

Per Market Research Future, the global insulin market is expected to see a CAGR of 8.4% and reach a worth of $8.52 billion by 2023.

Recent Developments

Lately, Tandem Diabetes has made a major development, which has boosted the application of the t:slim X2 insulin pump.

Last December, the company received FDA clearance for the t:slim X2 insulin pump with Control-IQ technology. This is the first FDA-cleared system to deliver automatic correction boluses, along with adjusting insulin to help prevent high and low blood sugar.

In September 2019, it received Health Canada approval for the t:slim X2 insulin pump with Basal-IQ technology. With this, starting from February 2020, all in-warranty t:slim X2 pump users in Canada now have the option to integrate Basal-IQ technology to their existing pump free of cost via remote software update.

Price Performance

Shares of this company have surged 15.2% in a year, as against the industry’s 4.5% decline.

Zacks Rank and Key Picks

Tandem Diabetes currently carries a Zacks Rank # 3 (Hold).

A few better-ranked stocks from the broader medical space are ResMed RMD, Medtronic MDT and Hill-Rom Holdings HRC.

ResMed has an estimated long-term earnings growth rate of 12%. It currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Medtronic’s long-term earnings growth rate is projected at 7.4%. The company presently carries a Zacks Rank of 2.

Hill-Rom’s long-term earnings growth rate is estimated at 11.1%. It carries a Zacks Rank #2, currently.

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