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 kind 1, kind 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 through a sensor with out the necessity for fingersticks or scanning.
The system has an total 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 methods.
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 permits finish customers to enter meal and drugs info.
The Dexcom Readability cellular app is suitable with a smartphone or pc and gives glucose patterns and statistics in addition to the means to share glucose knowledge with caregivers and relations.
In the meantime, the corporate is working with insulin pump companions to make sure Dexcom G7 15 Day can be suitable with automated insulin supply methods.
“The approval of Dexcom G7 15 Day marks one other main innovation for Dexcom,” Jake Leach, govt vice chairman and chief working officer at Dexcom, mentioned in a press release.
“By listening to the wants of our customers, we’re proud to supply the longest-lasting wearable and most correct CGM, giving individuals the information to higher management their diabetes with our best-in-class know-how. 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 knowledge partnership with Dexcom to combine glucose knowledge from the Dexcom G7 into its SimpleSense nanotechnology-enabled wearable.
Nanowear gives home-based, AI-enabled digital diagnostics for cardiometabolic well being. The corporate’s FDA-cleared SimpleSense wearable reads affected person vitals, together with respiration price, coronary heart price, blood strain, 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 knowledge move 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.
Through the partnership, customers of each firms’ merchandise gained entry to glucose knowledge from Dexcom glucose biosensors and sleep, coronary heart well being, stress, very important signal and exercise knowledge from the Oura Ring out there on Dexcom’s app and Oura’s app.
That very same 12 months, Dexcom expanded its diabetes-management capabilities and provided direct connectivity to the Apple Watch for its G7 CGM system through a devoted Bluetooth connection.
The characteristic offers customers the power to test 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 kinds of diabetes.
Different firms within the CGM area embrace Abbott, which in 2024 introduced its CGM system Lingo may very well be bought within the U.S. with no prescription.
Lingo comprises a biosensor and cellular app based mostly on Abbott’s FreeStyle Libre steady glucose monitoring know-how. The system is a biowearable product meant for individuals 18 and older who will not be taking insulin.
The system tracks glucose in actual time and gives finish customers with private insights and training with the goal of serving to construct wholesome habits, retrain metabolism and enhance total 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 scale of earlier Medtronic CGMs.
The Simplera platform featured the corporate’s CGM kind issue and included the Simplera CGM designed for use as a part of a Sensible MDI system with the InPen sensible 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 collection insulin pumps because of the pumps’ doubtlessly shortened battery life.
The corporate notified prospects that they need to monitor their MiniMed pump’s built-in alarms and alerts to maintain observe of battery standing and get in touch with the corporate in the event that they discover adjustments within the pump’s battery life.
