Glucose tracking specialist Dexcom introduced it won FDA clearance for its G7 15 Day steady glucose tracking (CGM) machine for other folks 18 and older with sort 1, sort 2 and gestational diabetes.
G7 15 Day, scheduled to release in the second one part of this yr, can have a fifteen.5-day put on time (together with a 12-hour grace duration) and closing 15% longer than Dexcom G7, in step with the corporate.
The brand new machine sends real-time glucose data to the Dexcom G7 app or receiver each and every 5 mins by way of a sensor with out the will for fingersticks or scanning.
The machine has an general imply absolute relative distinction (MARD) of 8.0%. In keeping with the NIH Nationwide Library of Drugs, MARD is a parameter used to characterize the size efficiency of CGM methods.
Dexcom G7 is water resistant and hands-free and has the power to attach the sensor at once to an Apple Watch.
It additionally has an automatic task logging characteristic that permits finish customers to enter meal and drugs data.
The Dexcom Readability cellular app is suitable with a smartphone or laptop and gives glucose patterns and statistics in addition to the method to proportion glucose knowledge with caregivers and members of the family.
In the meantime, the corporate is operating with insulin pump companions to verify Dexcom G7 15 Day shall be suitable with automatic insulin supply methods.
“The approval of Dexcom G7 15 Day marks some other main innovation for Dexcom,” Jake Leach, govt vice chairman and leader working officer at Dexcom, mentioned in a observation.
“Via being attentive to the wishes of our customers, we are proud to provide the longest-lasting wearable and maximum correct CGM, giving other folks the data to raised keep an eye on their diabetes with our best-in-class generation. This milestone units a brand new same old in CGM and is a testomony to our endured management in glucose biosensing.”
THE LARGER TREND
In March, cardiometabolic virtual diagnostics corporate Nanowear introduced a licensing and information partnership with Dexcom to combine glucose knowledge from the Dexcom G7 into its SimpleSense nanotechnology-enabled wearable.
Nanowear supplies home-based, AI-enabled virtual diagnostics for cardiometabolic fitness. The corporate’s FDA-cleared SimpleSense wearable reads affected person vitals, together with breathing price, middle price, blood power, bodily task and lung quantity.
In 2024, Dexcom made a $75 million strategic funding in health-tracking ring maker Oura and established a strategic partnership to permit two-way knowledge float between Dexcom’s CGM and the Oura Ring.
Dexcom contributed $75 million to Oura’s Collection D investment spherical, which introduced Oura’s valuation to greater than $5 billion.
By the use of the partnership, customers of each firms’ merchandise won get admission to to glucose knowledge from Dexcom glucose biosensors and sleep, middle fitness, rigidity, essential signal and task knowledge from the Oura Ring to be had on Dexcom’s app and Oura’s app.
That very same yr, Dexcom expanded its diabetes-management features and introduced direct connectivity to the Apple Stay up for its G7 CGM machine by way of a devoted Bluetooth connection.
The characteristic provides customers the power to test their glucose readings in genuine time with no need their iPhone in hand.
In 2022, Dexcom G7 CGM was once cleared via the FDA. That type was once for people ages two and older with all forms of diabetes.
Different firms within the CGM area come with Abbott, which in 2024 introduced its CGM machine Lingo might be bought within the U.S. and not using a prescription.
Lingo accommodates a biosensor and cellular app in accordance with Abbott’s FreeStyle Libre steady glucose tracking generation. The machine is a biowearable product meant for other folks 18 and older who don’t seem to be taking insulin.
The machine tracks glucose in genuine time and gives finish customers with non-public insights and training with the purpose of serving to construct wholesome behavior, retrain metabolism and give a boost to general fitness.
That very same yr, Medtronic won FDA clearance for the Simplera CGM, the corporate’s first disposable, all-in-one CGM, which is part the scale of earlier Medtronic CGMs.
The Simplera platform featured the corporate’s CGM shape issue and incorporated the Simplera CGM designed for use as a part of a Sensible MDI machine with the InPen sensible insulin pen and the Simplera Sync sensor, which was once designed to be built-in with the MiniMed 780G insulin machine.
Final yr, Medtronic issued a voluntary recall of its MiniMed 600 and 700 collection insulin pumps because of the pumps’ doubtlessly shortened battery existence.
The corporate notified consumers that they will have to track their MiniMed pump’s integrated alarms and signals to stay observe of battery standing and make contact with the corporate in the event that they realize adjustments within the pump’s battery existence.
