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

Dexcom Gains Approval For No-Calibration, 'Interoperable' CGM System

 
• By Sue Darcey and David Filmore

US FDA's March 27 de novo clearance of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for diabetics gives Dexcom a no-calibration offering, a first-in-class "interoperable" system and sets out a streamlined regulatory pathway for future CGM devices with similar features.

US FDA has approved the Dexcom G6 iCGM system, the first type of continuous glucose monitor for diabetics that can be part of an integrated system with other compatible insulin dosing systems, insulin pumps or blood glucose meters.

It's also Dexcom Inc.'s first CGM that does not require calibration by the user during its 10-day use period, measuring up to a key competitor launched last fall,

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

Medtronic To Spin Out Diabetes Unit As New Products Solidify Turn-Around Story

 
• By Shubham Singh

Medtronic’s diabetes spin-out – a process likely to run up to 18 months and involve 20% IPO followed by a split-off for Medtronic shareholders – will allow firm to focus on higher-margin devices.

Abbott’s FreeStyle Libre CGM Reduces Cardiovascular Disease-Related Hospitalization

 
• By Natasha Barrow

The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.

Roche To Localize CGM Manufacturing in US with $550M Indiana Site Investment

 
• By Shubham Singh

Roche’s Indianapolis site currently produces 5.2 billion Accu-Chek test strips annually and supports distribution to 53 countries. The new CGM line will add to an already diversified operational footprint, which includes R&D, laboratories, manufacturing, and IT services.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

More from Device Area

Bone Surgery Startup Surgify Medical Raises $7.9m

 
• By Natasha Barrow

Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.

German Bionic Launches ‘Strongest Exoskeleton To Date’

 
• By Natasha Barrow

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.

Medtronic To Spin Out Diabetes Unit As New Products Solidify Turn-Around Story

 
• By Shubham Singh

Medtronic’s diabetes spin-out – a process likely to run up to 18 months and involve 20% IPO followed by a split-off for Medtronic shareholders – will allow firm to focus on higher-margin devices.