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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

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.

Research Finds Benefit From DME Suppliers For People Living With Diabetes

 
• By Elizabeth Orr

People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.

Dexcom Faces US FDA Warning Amid Agency Review Of 15-Day Sensor

 
• By Shubham Singh

Even if manufacturing challenges don’t derail the 2025 launch plans, the regulatory setback introduces new challenges for Dexcom’s continuous glucose monitors at a time when competition from Abbott and Medtronic is intensifying.

More from Device Area

‘Preparing For Regulatory Milestones, Commercial Launch’ Are Priorities, Says New Freenome CEO Aaron Elliott

 
• By Marion Webb

Freenome plans to file for US FDA approval of its blood-based screening test for colorectal cancer mid-year. If cleared, the test would rival Guardant Health’s Shield, the first FDA-cleared blood test for primary screening of colorectal cancer. Exact Sciences is also in the race to bring a blood-based colorectal screening test to market.

LSI 2025: Egg Medical Builds ‘Nests’ Around Interventional Cardiologists To Protect Against Scatter Radiation

 
• By Marion Webb

Egg Medical is ramping up efforts to expand international sales of its EggNest scatter radiation protection system to shield X-ray procedure room staff without disrupting workflow. Medtech Insight sat down with Bob Wilson, Egg Medical’s CEO, to discuss the various EggNest systems, marketing opportunities and the competitive landscape.

CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 
• By Natasha Barrow

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.