Glucose monitoring specialist Dexcom introduced it obtained FDA clearance for its G7 15 Day steady glucose monitoring (CGM) system for individuals 18 and older with sort 1, sort 2 and gestational diabetes.
G7 15 Day, scheduled to launch within the second half of this 12 months, can have a 15.5-day put on time (together with a 12-hour grace interval) and final 15% longer than Dexcom G7, based on the corporate.
The brand new system sends real-time glucose info to the Dexcom G7 app or receiver each 5 minutes by way of a sensor with out the necessity for fingersticks or scanning.
The system has an general imply absolute relative distinction (MARD) of 8.0%. Based on the NIH Nationwide Library of Drugs, MARD is a parameter used to characterize the measurement efficiency of CGM programs.
Dexcom G7 is waterproof and hands-free and has the power to join the sensor on to an Apple Watch.
It additionally has an automatic exercise logging characteristic that enables finish customers to enter meal and drugs info.
The Dexcom Readability cell app is suitable with a smartphone or laptop and offers glucose patterns and statistics in addition to the means to share glucose information with caregivers and relations.
In the meantime, the corporate is working with insulin pump companions to make sure Dexcom G7 15 Day will probably be suitable with automated insulin supply programs.
“The approval of Dexcom G7 15 Day marks one other main innovation for Dexcom,” Jake Leach, government vice chairman and chief working officer at Dexcom, mentioned in an announcement.
“By listening to the wants of our customers, we’re proud to supply the longest-lasting wearable and most correct CGM, giving individuals the data to higher management their diabetes with our best-in-class expertise. This milestone units a brand new commonplace in CGM and is a testomony to our continued management in glucose biosensing.”
THE LARGER TREND
In March, cardiometabolic digital diagnostics firm Nanowear introduced a licensing and information partnership with Dexcom to combine glucose information from the Dexcom G7 into its SimpleSense nanotechnology-enabled wearable.
Nanowear offers home-based, AI-enabled digital diagnostics for cardiometabolic well being. The corporate’s FDA-cleared SimpleSense wearable reads affected person vitals, together with respiration charge, coronary heart charge, blood stress, bodily exercise and lung quantity.
In 2024, Dexcom made a $75 million strategic funding in health-tracking ring maker Oura and established a strategic partnership to allow two-way information circulate between Dexcom’s CGM and the Oura Ring.
Dexcom contributed $75 million to Oura’s Sequence D funding spherical, which introduced Oura’s valuation to greater than $5 billion.
By way of the partnership, customers of each firms’ merchandise gained entry to glucose information from Dexcom glucose biosensors and sleep, coronary heart well being, stress, very important signal and exercise information from the Oura Ring accessible on Dexcom’s app and Oura’s app.
That very same 12 months, Dexcom expanded its diabetes-management capabilities and supplied direct connectivity to the Apple Watch for its G7 CGM system by way of a devoted Bluetooth connection.
The characteristic provides customers the power to examine their glucose readings in actual time with out having their iPhone in hand.
In 2022, Dexcom G7 CGM was cleared by the FDA. That mannequin was for people ages two and older with all sorts of diabetes.
Different firms within the CGM area embrace Abbott, which in 2024 introduced its CGM system Lingo might be bought within the U.S. and not using a prescription.
Lingo comprises a biosensor and cell app primarily based on Abbott’s FreeStyle Libre steady glucose monitoring expertise. The system is a biowearable product supposed for individuals 18 and older who usually are not taking insulin.
The system tracks glucose in actual time and offers finish customers with private insights and training with the goal of serving to construct wholesome habits, retrain metabolism and enhance general well being.
That very same 12 months, Medtronic obtained FDA clearance for the Simplera CGM, the corporate’s first disposable, all-in-one CGM, which is half the dimensions of earlier Medtronic CGMs.
The Simplera platform featured the corporate’s CGM type issue and included the Simplera CGM designed for use as a part of a Good MDI system with the InPen good insulin pen and the Simplera Sync sensor, which was designed to be built-in with the MiniMed 780G insulin system.
Final 12 months, Medtronic issued a voluntary recall of its MiniMed 600 and 700 sequence insulin pumps as a result of pumps’ doubtlessly shortened battery life.
The corporate notified clients that they need to monitor their MiniMed pump’s built-in alarms and alerts to maintain observe of battery standing and call the corporate in the event that they discover adjustments within the pump’s battery life.
