1. Medtech Insight
  2. >>Device Area
  3. >>Diabetic Care

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,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Diabetic Care

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Medtronic’s MiniMed Expands EU Uses Of MiniMed 780G And Readies For US Expansion Amid Competition

 
• By Shubham Singh

The timing aligns with Medtronic’s plan to spin off its $2.8bn diabetes unit, now named MiniMed. As a standalone entity, MiniMed will be more responsive to competition, regulatory shifts, and the diabetes technology needs of healthcare systems.

Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 
• By Brian Bossetta

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

More from Device Area

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

Medtech M&A Resurges: How To Define Startup Exit Strategy

 
• By Natasha Barrow

The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.

Intuitive Surgical Sees Early Wins With Da Vinci 5, Lifts FY25 Guidance As Tariff Impact Eases

 
• By Shubham Singh

For the full year, the company now expects tariffs to increase the cost of sales by approximately 1% of revenue, plus or minus 20 basis points. This is lower than the previous estimate of approximately 1.7% of revenue. The updated gross margin guidance for 2025 is 66%-67%, up from 65%-66.5%.