Tandem Diabetes Care Inc. (NASDAQ: TNDM) shares made a solid gain early on Friday after the firm announced a key approval from the U.S. Food and Drug Administration (FDA).

As we have said before, FDA approvals have the potential to make or break companies, and so far this year Tandem just seems to keep rolling out the hits. This company has absolutely rocked the health care sector and is up over 760% in 2018 alone.

The FDA announced the approval of the t:slim X2 Insulin Pump with Basal-IQ technology, a predictive low glucose suspend feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia).

Note that this is the first automated insulin delivery system approved for use by children as young as six years old, and the first insulin pump designated as compatible with integrated continuous glucose monitoring (iCGM) devices.

The company plans to launch its new product with Dexcom G6 continuous glucose monitoring (CGM) integration, which requires no fingersticks for calibration or diabetes treatment decisions and was the first CGM device to receive the iCGM designation from the FDA earlier this year.

Tandem expects the t:slim X2 Pump with Basal-IQ technology to be available in August 2018, and all in-warranty t:slim X2 users in the United States will have the option to add the new feature free of charge via remote software update.

What’s interesting about Tandem’s Basal-IQ algorithm is that it is designed to look 30 minutes into the future to predict where glucose levels are heading. The device suspends insulin delivery when low glucose is predicted, then automatically resumes insulin delivery once glucose levels begin to rise.

Shares of Tandem were last seen up about 12% at $22.82, with a consensus analyst price target of $14.75 and a 52-week range of $2.14 to $25.50.

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