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Tandem’s CSO Speaks On Insulin Pump Development And Its Challenges

 
• By Barnaby Pickering

Insulin pumps have lagged behind continuous glucose monitors in terms of market penetration due to their cost and the complex regulatory framework that surrounds them. Elizabeth Gasser, chief strategy officer at Tandem Diabetes spoke to Medtech Insight about these challenges and how the company is taking a slightly different approach to pumps.

Tandem's t:slim X2 pump • Source: Tandem Diabetes

Continuous glucose monitors like DexCom’s G6 and G7 and Abbott’s FreeStyle Libre 2 and 3 have blurred the line between medical devices and consumer goods. Packaged alongside sleek smartphone apps and marketed directly to patients, CGMs have changed the game for diabetics, payers and doctors looking to recommend therapies. 

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More from Diabetic Care

Biolinq’s $100M In Series C Financing Supports Efforts To Bring Diabetic Glucose Monitoring With Needle-Free Patch To Market

 
• By Marion Webb

Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

Dexcom Promotes CGM As First-Line Tool In Type 2 Diabetes

 
• By Shubham Singh

Only 14% of people with type 2 diabetes use continuous glucose monitors, although 93% of users report a positive impact on their health. Dexcom is ramping up efforts to close this adoption gap.

Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
• By Marion Webb

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

Dexcom’s FDA Warning Letter Shows Risks Of Driving Margin As Firm Aims To Launch 15-Day Sensor

 
• By Shubham Singh

After switching production of coatings for its continuous glucose monitors in-house to improve supply, Dexcom ran afoul of US FDA for failing to submit a premarket notification. Firm says launch of 15-day sensor will not be delayed by the problems.

More from Device Area

FDA Issues A Pair Of Early Alerts For Intravascular Catheters

 
• By Brian Bossetta

The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.

Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

 
• By Elizabeth Orr

The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.

Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D

 
• By Marion Webb

Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.