FDA Approves AID Technology for Pregnancy Use in Type 1 Diabetes
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 27 2026
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Should l Buy TNDM?
Source: Newsfilter
- FDA Approval: The FDA has cleared Tandem Diabetes' Control-IQ+ automated insulin delivery technology for use in pregnant women with type 1 diabetes, making it the first commercially available AID system for pregnancy in the U.S., representing a significant advancement in diabetes management.
- Clinical Trial Results: In the CIRCUIT trial, participants using Control-IQ experienced a 12.6% increase in time spent in the target glucose range during pregnancy, equating to approximately three additional hours per day, highlighting the technology's potential to improve pregnancy outcomes.
- Healthcare Training Initiatives: Tandem Diabetes will conduct a series of training events for healthcare providers, with the first event scheduled at the 2026 American Diabetes Association Scientific Sessions, aimed at enhancing awareness and application of diabetes management during pregnancy.
- Long-term Strategic Impact: This FDA approval not only enhances Tandem's competitive position in the market but also provides a safer and more effective management option for pregnant diabetes patients, which is expected to drive future sales growth and brand influence.
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Analyst Views on TNDM
Wall Street analysts forecast TNDM stock price to rise
18 Analyst Rating
8 Buy
10 Hold
0 Sell
Moderate Buy
Current: 18.470
Low
14.00
Averages
26.33
High
55.00
Current: 18.470
Low
14.00
Averages
26.33
High
55.00
About TNDM
Tandem Diabetes Care, Inc. is a global insulin delivery and diabetes technology company that manufactures and sells advanced automated insulin delivery systems. Its pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology. Its t:slim X2 and Tandem Mobi pumps can be used with a variety of infusion sets to offer patients choice in how and where their pump is worn. In addition, they are software updatable from a personal computer and compatible with its Web-based data management application. Both pumps feature its Control-IQ advanced hybrid closed loop technology, with an automated insulin delivery (AID) feature designed to help increase a user's time in the targeted glycemic range. There are two primary therapies used by people with insulin-dependent diabetes, Multiple Daily Injection (MDI) and insulin pumps. As part of its AID systems, it offers pump integration with multiple CGM sensors.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Tandem (TNDM) Q1 2026 Earnings Transcript
See More
FDA Approves AID Technology for Pregnancy Use in Type 1 Diabetes
- FDA Approval: The FDA has cleared Tandem Diabetes' Control-IQ+ automated insulin delivery technology for use in pregnant women with type 1 diabetes, making it the first commercially available AID system for pregnancy in the U.S., representing a significant advancement in diabetes management.
- Clinical Trial Results: In the CIRCUIT trial, participants using Control-IQ experienced a 12.6% increase in time spent in the target glucose range during pregnancy, equating to approximately three additional hours per day, highlighting the technology's potential to improve pregnancy outcomes.
- Healthcare Training Initiatives: Tandem Diabetes will conduct a series of training events for healthcare providers, with the first event scheduled at the 2026 American Diabetes Association Scientific Sessions, aimed at enhancing awareness and application of diabetes management during pregnancy.
- Long-term Strategic Impact: This FDA approval not only enhances Tandem's competitive position in the market but also provides a safer and more effective management option for pregnant diabetes patients, which is expected to drive future sales growth and brand influence.
See More
Tandem Diabetes Care's Control-IQ+ Automated Insulin Delivery System Receives FDA Approval for Use During Pregnancy in Type 1 Diabetes
New Technology Approval: Tandem Diabetes Care's Control-IQ automated insulin delivery technology has been cleared for use in pregnant women with Type 1 diabetes.
Impact on Diabetes Management: This approval is significant as it enhances diabetes management options for pregnant individuals, potentially improving health outcomes for both mothers and babies.
See More
Tandem Diabetes Care Under Investigation for Securities Fraud
- Securities Fraud Investigation: The Portnoy Law Firm has initiated an investigation into Tandem Diabetes Care (NASDAQ:TNDM) for possible securities fraud, indicating serious concerns regarding corporate governance and investor protection.
- Stock Price Plunge: On August 7, 2025, Tandem's stock price fell by $2.87, or 19.9%, closing at $11.52 per share, directly impacting investors' financial positions and reflecting a decline in market confidence regarding the company's product safety.
- Product Defect Disclosure: The company disclosed on August 7 a newly identified malfunction in its insulin pumps that could lead to “insulin delivery discontinuation,” potentially resulting in hyperglycemia and requiring medical intervention, heightening investor anxiety.
- Customer Notification Timing: Tandem had already notified affected customers between July 22 and 24, 2025, prior to public disclosure, indicating a lack of transparency in addressing product safety issues, which may increase potential legal liabilities.
See More
Tandem Diabetes Care Upgraded by Truist Amid New Strategy
- Rating Upgrade: Truist upgraded Tandem Diabetes Care from Hold to Buy, reflecting market recognition of its new pay-as-you-go pharmacy channel strategy, which is expected to drive future revenue growth.
- Economic Gains Outlook: Piper Sandler also upgraded the company from Neutral to Overweight, arguing that the new strategy will significantly improve Tandem's revenue performance over the next three years, despite anticipated challenges in 2026/27.
- Growth Potential Analysis: Truist analyst Richard Newitter noted that the market has yet to fully appreciate the growth trajectory of the company's higher-margin recurring revenue, particularly as it transitions to the new model, which is expected to enhance profitability.
- Investment Value Assessment: Tandem's stock is currently trading at approximately 1.3 times its 2027 revenue, with Newitter raising the price target from $27 to $35 per share, believing the market underestimates the company's growth and profitability prospects under the new business model.
See More
Tandem Diabetes Shares Rise After Upgrade by Piper Sandler
- Market Estimate Adjustment: Analyst Matt O'Brien from Piper Sandler notes that the market has yet to fully reflect Tandem Diabetes' recent shift to a pay-as-you-go pharmacy channel, which is expected to significantly enhance the company's long-term revenue.
- Revenue Model Shift: While the new strategy results in no upfront payments for pump sales through pharmacies, the annual supply revenue per patient reaches $4,200, which is four times greater than sales through the DME channel, indicating higher long-term profit potential.
- Long-Term Revenue Expectations: O'Brien anticipates that the new economic model will boost Tandem's revenue over the next three years, particularly in 2028, with an expected additional $8,500 revenue per patient, thereby improving the company's EV/sales multiple.
- Rating and Price Target Upgrade: Piper Sandler upgraded Tandem's rating from Neutral to Overweight and raised the price target from $21 to $33 per share, reflecting confidence in the company's future growth prospects.
See More
Tandem (TNDM) Q1 2026 Earnings Transcript
See More
FDA Approves AID Technology for Pregnancy Use in Type 1 Diabetes
- FDA Approval: The FDA has cleared Tandem Diabetes' Control-IQ+ automated insulin delivery technology for use in pregnant women with type 1 diabetes, making it the first commercially available AID system for pregnancy in the U.S., representing a significant advancement in diabetes management.
- Clinical Trial Results: In the CIRCUIT trial, participants using Control-IQ experienced a 12.6% increase in time spent in the target glucose range during pregnancy, equating to approximately three additional hours per day, highlighting the technology's potential to improve pregnancy outcomes.
- Healthcare Training Initiatives: Tandem Diabetes will conduct a series of training events for healthcare providers, with the first event scheduled at the 2026 American Diabetes Association Scientific Sessions, aimed at enhancing awareness and application of diabetes management during pregnancy.
- Long-term Strategic Impact: This FDA approval not only enhances Tandem's competitive position in the market but also provides a safer and more effective management option for pregnant diabetes patients, which is expected to drive future sales growth and brand influence.
See More
Tandem Diabetes Care's Control-IQ+ Automated Insulin Delivery System Receives FDA Approval for Use During Pregnancy in Type 1 Diabetes
New Technology Approval: Tandem Diabetes Care's Control-IQ automated insulin delivery technology has been cleared for use in pregnant women with Type 1 diabetes.
Impact on Diabetes Management: This approval is significant as it enhances diabetes management options for pregnant individuals, potentially improving health outcomes for both mothers and babies.
See More
Tandem Diabetes Care Under Investigation for Securities Fraud
- Securities Fraud Investigation: The Portnoy Law Firm has initiated an investigation into Tandem Diabetes Care (NASDAQ:TNDM) for possible securities fraud, indicating serious concerns regarding corporate governance and investor protection.
- Stock Price Plunge: On August 7, 2025, Tandem's stock price fell by $2.87, or 19.9%, closing at $11.52 per share, directly impacting investors' financial positions and reflecting a decline in market confidence regarding the company's product safety.
- Product Defect Disclosure: The company disclosed on August 7 a newly identified malfunction in its insulin pumps that could lead to “insulin delivery discontinuation,” potentially resulting in hyperglycemia and requiring medical intervention, heightening investor anxiety.
- Customer Notification Timing: Tandem had already notified affected customers between July 22 and 24, 2025, prior to public disclosure, indicating a lack of transparency in addressing product safety issues, which may increase potential legal liabilities.
See More
Tandem Diabetes Care Upgraded by Truist Amid New Strategy
- Rating Upgrade: Truist upgraded Tandem Diabetes Care from Hold to Buy, reflecting market recognition of its new pay-as-you-go pharmacy channel strategy, which is expected to drive future revenue growth.
- Economic Gains Outlook: Piper Sandler also upgraded the company from Neutral to Overweight, arguing that the new strategy will significantly improve Tandem's revenue performance over the next three years, despite anticipated challenges in 2026/27.
- Growth Potential Analysis: Truist analyst Richard Newitter noted that the market has yet to fully appreciate the growth trajectory of the company's higher-margin recurring revenue, particularly as it transitions to the new model, which is expected to enhance profitability.
- Investment Value Assessment: Tandem's stock is currently trading at approximately 1.3 times its 2027 revenue, with Newitter raising the price target from $27 to $35 per share, believing the market underestimates the company's growth and profitability prospects under the new business model.
See More
Tandem Diabetes Shares Rise After Upgrade by Piper Sandler
- Market Estimate Adjustment: Analyst Matt O'Brien from Piper Sandler notes that the market has yet to fully reflect Tandem Diabetes' recent shift to a pay-as-you-go pharmacy channel, which is expected to significantly enhance the company's long-term revenue.
- Revenue Model Shift: While the new strategy results in no upfront payments for pump sales through pharmacies, the annual supply revenue per patient reaches $4,200, which is four times greater than sales through the DME channel, indicating higher long-term profit potential.
- Long-Term Revenue Expectations: O'Brien anticipates that the new economic model will boost Tandem's revenue over the next three years, particularly in 2028, with an expected additional $8,500 revenue per patient, thereby improving the company's EV/sales multiple.
- Rating and Price Target Upgrade: Piper Sandler upgraded Tandem's rating from Neutral to Overweight and raised the price target from $21 to $33 per share, reflecting confidence in the company's future growth prospects.
See More
