Glucose monitoring skilled Dexcom introduced that it has acquired FDA approval for its G7 15-day Steady Glucose Monitoring (CGM) system for individuals with kind 18 and older, kind 2, kind 2 and gestational diabetes.
The G7 15-day is scheduled to be launched within the second half of this 12 months and could have 15.5 days of wear and tear time (The corporate stated that it features a 12-hour grace interval, 15% longer than the Dexcom G7.
The brand new system sends real-time glucose data to the Dexcom G7 utility or by way of the sensor each 5 minutes every time the receiver will not be required to do a fingertip or scan.
General The imply absolute distinction (MARD) was 8.0%. In response to the NIH Nationwide Library of Medication, MARD is a parameter used to characterize the measurement efficiency of CGM techniques.
The Dexcom G7 is waterproof and foolish, and succesful Join the sensor on to the Apple Watch.
It additionally has an automatic exercise recording characteristic that enables finish customers to enter meal and medicine data.
The Dexcom Readability cell app is suitable with smartphones or computer systems and gives glucose patterns and statistics, in addition to technique of sharing glucose information with caregivers and members of the family.
In the meantime, the corporate is working with insulin pump companions to make sure that the Dexcom G7 is suitable with the automated insulin supply system for 15 days.
“The 15-day approval of the Dexcom G7 marks one other main innovation for Dexcom,” stated Jake Leach, govt vp and chief working officer of Dexcom in an announcement.
“By listening to customers’ wants, we’re proud to supply the longest wearable and most correct CGM, permitting individuals to higher management their diabetes by way of our best-in-class expertise. This milestone is a brand new normal for CGM, which is a testomony to our ongoing management in glucose bioefficiency.”
An even bigger development
In March, Cardiac Metabolism Digital Diagnostics Firm NanoWear introduced a licensing and information partnership with Dexcom to combine the glucose information from the Dexcom G7 into its SimpleSense nanotechnology wearable gadgets.
NanoWear gives family-based, AI-enabled digital analysis for cardiac metabolic well being. The corporate’s FDA clearance analog wearable wearable readings together with respiration charge, coronary heart charge, blood stress, bodily train and lung quantity.
Dexcom earned $75 million in 2024 Strategic funding in well being monitoring ring producer OURA and a strategic partnership has been established to realize bidirectional information move between Dexcom’s CGM and OURA rings.
Dexcom contributed $75 million to OURA’s Sequence D funding spherical, bringing Oura’s valuation to $5 billion.
go The partnership between each firms’ customers has obtained glucose information obtainable from Dexcom’s glucose biosensor and sleep, coronary heart well being, stress, very important indicators and exercise information.
In the identical 12 months, Dexcom expanded Diabetes administration options and gives direct connectivity straight with the Apple Watch’s G7 CGM system through a devoted Bluetooth connection.
This characteristic allows customers to test their glucose readings in actual time with out having to grasp their iPhone.
In 2022, Dexcom G7 CGM is cleared by the FDA. This mannequin is appropriate for all older individuals with all sorts of diabetes.
Different firms within the CGM house embrace Abbott introduced in 2024 that its CGM system time period could be bought in america with out prescriptions.
The time period contains biosensors and cell purposes based mostly on Abbott’s freestyle steady glucose monitoring expertise. The system is a bioavailable product for individuals aged 18 and older who should not taking insulin.
The system tracks glucose in actual time and gives finish customers with private insights and steering to assist develop wholesome habits, retrain metabolism and enhance general well being.
identical 12 months, Medtronic obtained the FDA’s CGM, the corporate’s first one-time all-in-one CGM, which is half the Medtronic CGM.
The Simpleera platform options the corporate’s CGM kind and contains Simpleera CGM, designed to make use of the INPEN good insulin pen and Simpleera Sync Sensor as a part of the good MDI system, which is designed to combine with the smallest 780G 780G insulin system.
Final 12 months, Medtronic Its smallest 600 and 700 collection insulin pumps are voluntarily recalled as a result of potential shortening of battery life.
The corporate notifies clients that they need to monitor their minimizing pumps’ built-in alarms and alarms to trace battery standing and get in touch with the corporate when the corporate notices modifications in pump battery life.
