Nanowear, Inc.

Glucose monitoring specialist Dexcom announced it received FDA clearance for its G7 15 Day continuous glucose monitoring (CGM) system for people 18 and older with type 1, type 2 and gestational diabetes. G7 15 Day, scheduled to launch in the second half of this year, will have a 15.5-day wear time (including a 12-hour grace period) and last 15% longer than Dexcom G7, according to the company. The new system sends real-time glucose information to the Dexcom G7 app or receiver every five minutes via a sensor without the need for fingersticks or scanning. The system has an overall mean absolute relative difference (MARD) of 8.0%. According to the NIH National Library of Medicine, MARD is a parameter used to characterize the measurement performance of CGM systems. Dexcom G7 is waterproof and hands-free and has the ability to connect the sensor directly to an Apple Watch. It also has an automated activity logging feature that allows end users to input meal and medication information. The Dexcom Clarity mobile app is compatible with a smartphone or computer and provides glucose patterns and statistics as well as the means to share glucose data with caregivers and family members. Meanwhile, the company is working with insulin pump partners to ensure Dexcom G7 15 Day will be compatible with automated insulin delivery systems. "The approval of Dexcom G7 15 Day marks another major innovation for Dexcom," Jake Leach, executive vice president and chief operating officer at Dexcom, said in a statement. "By listening to the needs of our users, we're proud to offer the longest-lasting wearable and most accurate CGM, giving people the knowledge to better control their diabetes with our best-in-class technology. This milestone sets a new standard in CGM and is a testament to our continued leadership in glucose biosensing." THE LARGER TREND In March, cardiometabolic digital diagnostics company Nanowear announced a licensing and data partnership with Dexcom to integrate glucose data from the Dexcom G7 into its SimpleSense nanotechnology-enabled wearable. Nanowear provides home-based, AI-enabled digital diagnostics for cardiometabolic health. The company's FDA-cleared SimpleSense wearable reads patient vitals, including respiration rate, heart rate, blood pressure, physical activity and lung volume. In 2024, Dexcom made a $75 million strategic investment in health-tracking ring maker Oura and established a strategic partnership to enable two-way data flow between Dexcom's CGM and the Oura Ring. Dexcom contributed $75 million to Oura's Series D funding round, which brought Oura's valuation to more than $5 billion. Via the partnership, users of both companies' products gained access to glucose data from Dexcom glucose biosensors and sleep, heart health, stress, vital sign and activity data from the Oura Ring available on Dexcom's app and Oura's app. That same year, Dexcom expanded its diabetes-management capabilities and offered direct connectivity to the Apple Watch for its G7 CGM system via a dedicated Bluetooth connection. The feature gives users the ability to check their glucose readings in real time without having their iPhone in hand. In 2022, Dexcom G7 CGM was cleared by the FDA. That model was for individuals ages two and older with all types of diabetes. Other companies in the CGM space include Abbott, which in 2024 announced its CGM system Lingo could be purchased in the U.S. without a prescription. Lingo contains a biosensor and mobile app based on Abbott's FreeStyle Libre continuous glucose monitoring technology. The system is a biowearable product intended for people 18 and older who are not taking insulin. The system tracks glucose in real time and provides end users with personal insights and coaching with the aim of helping build healthy habits, retrain metabolism and improve overall health. That same year, Medtronic received FDA clearance for the Simplera CGM, the company's first disposable, all-in-one CGM, which is half the size of previous Medtronic CGMs. The Simplera platform featured the company's CGM form factor and included the Simplera CGM designed to be used as part of a Smart MDI system with the InPen smart insulin pen and the Simplera Sync sensor, which was designed to be integrated with the MiniMed 780G insulin system. Last year, Medtronic issued a voluntary recall of its MiniMed 600 and 700 series insulin pumps due to the pumps' potentially shortened battery life. The company notified customers that they should monitor their MiniMed pump's built-in alarms and alerts to keep track of battery status and contact the company if they notice changes in the pump's battery life.

Cardiometabolic digital diagnostics company Nanowear announced a licensing and data partnership with glucose monitoring specialist Dexcom to integrate glucose data from the Dexcom G7 into its SimpleSense nanotechnology-enabled wearable. Nanowear offers home-based, AI-enabled digital diagnostics for cardiometabolic health. The company's FDA-cleared SimpleSense wearable reads patient vitals, such as respiration rate, heart rate, blood pressure, physical activity, lung volume and more. It uses cloth-based nanosensor technology to capture more than 120 million data points daily. The platform then uses AI to analyze the data and then generate reports for physicians on the data gathered. Dexcom G7 is an FDA-cleared continuous glucose monitoring system worn on the back of the upper arm or upper buttocks that can be used by people with all types of diabetes and who are 2 years old and older. The wearable monitor measures blood sugar levels and sends glucose readings to a smartphone or app every five minutes. Through the partnership, Nanowear will ingest glucose data from Dexcom G7's continuous glucose monitoring system alongside Nanowear's cardiovascular biomarkers, which the company says will allow clinical researchers to obtain real-world and real-time cardiometabolic diagnostic assessments. "The promise of digital health over a decade ago was precision medicine and individualized care that would save patients, providers and payers time and money while promoting better outcomes and experience," Venk Varadan, CEO and cofounder of Nanowear, told MobiHealthNews in an email. "Gen 1 and Gen 2 solutions, while successful in building awareness, never truly accomplished this goal holistically and diagnostically. Being able to passively quantify the relationship via AI between glucose tolerance/insulin sensitivity and hypertension, arrhythmia, sleep apnea, heart failure, etc., is going to be a proven cardiometabolic solution in precision medicine and individualized care — and Nanowear can now do that." THE LARGER TREND Nanowear received FDA clearance for its AI-enabled SimpleSense-BP and SimpleSense-BP Software Application in December 2023. In 2021, the company received software-only FDA 510(k) clearance, enabling it to implement standalone AI and deep learning algorithms to inform remote diagnoses as software-as-a-medical device in forthcoming AI-based diagnostics in a closed-loop hospital-at-home network. In November, Dexcom announced it made a $75 million strategic investment in health-tracking ring maker Oura, bringing its valuation to more than $5 billion. The companies also announced a strategic partnership to enable two-way data flow between Dexcom's CGM and the Oura Ring. Dexcom also announced it expanded its diabetes-management capabilities by offering direct connectivity to the Apple Watch for its G7 continuous glucose monitoring system via a dedicated Bluetooth connection. The glucose monitoring company secured FDA clearance for its over-the-counter CGM tool, Stelo. The device is available without requiring a prescription, and the wearable biosensor boasts a battery life of up to two weeks and adheres to the back of the upper arm. In 2023, Dexcom announced a partnership with digital chronic condition management platform DarioHealth to allow Dario's digital health tools for metabolic health to include data from Dexcom CGMs.

Some of the most challenging yet most important processes for digital health startups to navigate are those related to reimbursement and coding. “People think, ‘Oh, I’ve got a code. I’m great. I can just go to the market and I’m going to get all the money.’ But it doesn’t work that way. You have to make sure that the insurer will cover you with that code and that the payment is commensurate with what you’d like the price to be,” said Renée Arnold, entrepreneur-in-residence at BioHealth Innovation and the National Institutes of Health, during a recent conference. She made these remarks last week during a session at the Heart Rhythm Society’s HRX conference in Atlanta. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum Another panelist — Venk Varadan, CEO and co-founder of medical technology startup Nanowear — pointed out that digital startups usually segment their milestones into different phases. Often, a startup will focus on creating a viable product, then validate it with the clinical community and then start preparing for FDA approval — all before it begins to seriously consider the processes required to obtain coverage and codes — Varadan noted. “If I could have done it all over again, I really would have been thinking in parallel at the very beginning about reimbursement strategies,” he declared. Once a startup receives FDA approval for its product, the leadership team might discover that the existing reimbursement codes that they thought would work for their product actually don’t, Varadan said. For example, a startup selling a cardiac monitoring wearable device may think there is an existing code out there that would work for its product, but after reading the fine print, they might discover that their device wouldn’t qualify for reimbursement using existing codes. Codes tend to be specific about requirements — sometimes a device needs to collect a certain amount of data points or be used within a certain patient population, Varadan pointed out. presented by Health Tech The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani He and the rest of Nanowear’s leadership team learned about this by talking to potential users of their product, which is a remote diagnostics platform built on wearable cloth nanotechnology. Many potential customers said that they loved the idea of the product but probably wouldn’t be using it because they can’t be reimbursed for it, Varadan remarked. “So almost by accident, we kind of fell into our contract research organization model, where sponsors and CROs pay us to evaluate their own products. And the beauty there is, we’re collecting that real-world evidence in certain disease states, so one day we can go to CMS and say we’ve got data on these 2,000 patients with, for example, labile uncontrolled hypertension. We need a specific novitas code — here’s the data,” he explained. Collecting this data early on and getting a head start on preparing for the creation of a new code is something more startups may want to consider, Varadan said.