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Tandem Diabetes Care Gains FDA Clearance for SteadiSet

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Tandem Diabetes Care Gains FDA Clearance for SteadiSet

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An announcement from Tandem Diabetes Care ( (TNDM) ) is now available.

On August 6, 2025, Tandem Diabetes Care received FDA clearance for its SteadiSet infusion set, designed for up to seven days of insulin delivery for type 1 diabetes patients. The company plans to launch SteadiSet as a standalone product and as part of its future Tandem Mobi tubeless system, with a focus on scaling up manufacturing and pre-commercial activities in the coming quarters.

The most recent analyst rating on (TNDM) stock is a Hold with a $46.00 price target. To see the full list of analyst forecasts on Tandem Diabetes Care stock, see the TNDM Stock Forecast page.

Spark’s Take on TNDM Stock

According to Spark, TipRanks’ AI Analyst, TNDM is a Neutral.

Tandem Diabetes Care’s overall stock score is primarily impacted by its weak financial performance and bearish technical indicators. While the earnings call provided some optimism with strong international growth and product development, the company’s high leverage and ongoing losses weigh heavily on its valuation and overall outlook.

To see Spark’s full report on TNDM stock, click here.

More about Tandem Diabetes Care

Tandem Diabetes Care operates in the medical device industry, focusing on products for diabetes management. The company specializes in insulin delivery systems, including insulin pumps and infusion sets, with a market focus on providing innovative solutions for people with diabetes.

Average Trading Volume: 1,605,208

Technical Sentiment Signal: Sell

Current Market Cap: $1.01B

For detailed information about TNDM stock, go to TipRanks’ Stock Analysis page.

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