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Tandem Diabetes Gets FDA Nod for t:slim X2 Insulin Pump

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Tandem Diabetes Care, Inc. TNDM recently announced the FDA clearance for the t:slim X2 insulin pump with Control-IQ advanced hybrid-closed loop technology. This follows the last-month’s receipt of the Canadian nod for the same pump with Basal-IQ technology.

The latest regulatory clearance is expected to accelerate Tandem Diabetes’ pump shipments within the United States and expand its customer base.

More About t:slim X2 With Control-IQ

The t:slim X2 insulin pump with Control-IQ technology uses Dexcom G6 CGM sensor values to forecast glucose levels and adjust insulin delivery to ensure the prevention of erratic highs and lows.

Control-IQ technology for the t:slim X2 insulin pump is the first automated insulin dosing software in a new interoperable automated glycemic controller category. This feature automatically adjusts insulin delivery to the patient by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).

Per Tandem Diabetes, this is the third category classified by the FDA for the interoperability of devices as a complete automated insulin dosing (AID) system.

Users of the existing t:slim X2 pumps can add this feature free of cost to their device via a remote software update (available by the end of Jan 2020). The new pumps with Control-IQ technology will begin shipping to customers in the same time frame.

Meanwhile, the company will continue offering the t:slim X2 pump with Basal-IQ predictive low glucose suspend technology as another treatment option.

Market Prospects

Per Transparency Market Research, the global insulin pumps market is projected to reach $9.50 billion by 2025 end. The market is anticipated to witness a CAGR of 9.80% during the 2017-2025 period. Hence, the latest FDA approval is well-timed.

Recent Developments

Lately, Tandem Diabetes is investing in several developments pertaining to the t:slim X2 insulin pump.

In this regard, in November 2019, the company clinched the Health Canada approval for the t:slim X2 insulin pump with Basal-IQ technology. Basal-IQ technology is a predictive low-glucose suspend algorithm, which utilizes sensor values from an integrated Dexcom G6 continuous glucose monitor to lower the frequency and duration of low-glucose events (hypoglycemia).

Price Performance

In the past year, the company’s shares have outperformed its industry. The stock has soared 81.5% compared with the industry’s 17.3% rally.

Zacks Rank and Other Key Picks

Tandem Diabetes currently carries a Zacks Rank #2 (Buy). A few other top-ranked stocks from the broader medical space are Haemonetics Corporation HAE, NuVasive, Inc NUVA and ResMed RMD. While ResMed sports a Zacks Rank #1 (Strong Buy), the other two carry the same top Zacks Rank as Tandem Diabetes. You can see the complete list of today’s Zacks #1 Rank stocks here.

Haemonetics has a projected long-term earnings growth rate of 13.5%.

NuVasive has an expected long-term earnings growth rate of 10.9%.

ResMed has a long-term earnings growth rate of 12.9%.

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