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Tandem Wins FDA Clearance On First Stand-Alone Glycemic Controller

 
• By Elizabeth Orr and Marion Webb

Tandem Diabetes Care received FDA clearance for its Control-IQ technology for use with Tandem's t:slim X2 insulin pump and Dexcom's G6 continuous glucose monitoring system, making it the first hybrid closed-loop system to deliver automatic correction boluses and adjust background insulin levels to help prevent high and low blood sugars.

T slim
Tandem's t:slim X2 insulin pump with Control-IQ technology is the first stand-alone insulin delivery device to win clearance from the US FDA. • Source: Courtesy Tandem Diabetes Care

An automated insulin delivery system that landed marketing authorization from the US Food and Drug Administration on 13 December represents a breakthrough for patients with type 1 diabetes.

Tandem Diabetes Care Inc.'s Control IQ is an automated insulin delivery system that combines the t:slim X2 insulin pump,...

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More from Diabetic Care

US CMS Sets Out Competitive Bidding Rental Model for CGMs; Abbott, Dexcom Could Face Impact

 
• By Shubham Singh

CMS is proposing to classify all CGMs and insulin pumps as “items requiring frequent and substantial servicing” to expand device choice and access for Medicare beneficiaries. Under this framework, CMS also intends to move Class II devices, which include CGMs from Abbott and Dexcom and pumps from Tan

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By Marion Webb

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

No Strings Attached: Big Players Chase Insulet In Fast-Growing Tubeless Insulin Pump Market

 
• By Marion Webb

Medtronic, Tandem and Beta Bionics are gearing up to bring tubeless patch pumps to market, chasing Insulet’s Omnipod 5, the only FDA-cleared patch pump for type 1 and type 2 diabetes. Analysts expect tubeless models to eventually displace durable pumps.

ADA 2025: Tandem Becomes Abbott’s Fourth Partner In Push To Advance Dual Sensor CGM Strategy

 
• By Marion Webb

Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.

More from Device Area

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By Elizabeth Orr

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

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Endo Tools, Fujifilm Partner to Fast-Track Endomina Rollout Across MEA Region

 
• By Shubham Singh

CEO Alexandre Chau told Medtech Insight that the Middle East and Africa presented the ideal mix of market potential, physician training opportunities, and regulatory readiness when the company was considering expansion markets beyond Europe and the US.