Diabetic Care
Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.
After switching production of coatings for its continuous glucose monitors in-house to improve supply, Dexcom ran afoul of US FDA for failing to submit a premarket notification. Firm says launch of 15-day sensor will not be delayed by the problems.
People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.
Even if manufacturing challenges don’t derail the 2025 launch plans, the regulatory setback introduces new challenges for Dexcom’s continuous glucose monitors at a time when competition from Abbott and Medtronic is intensifying.
Abbott’s international sales could be a key driver as firm looks to partnerships with insulin pump companies.
Tempering expectations on the immediate market impact for the upgraded continuous glucose monitor, Dexcom notes insurance coverage and pump integrations will take time to finalize.
Abbott is now offering its consumer CGM Lingo at Amazon for $49 for a single sensor. Its rival Dexcom also expects to introduce its consumer CGM Stelo on Amazon in Q1.
Several counties in the US state of Georgia are maternity care “deserts.” Remote monitoring of high-risk pregnancies with maternal hypertension and diabetes could help improve the state’s high rate of maternal mortality, according to leading health service provider Philips.
The digital health market includes thousands of app-based solutions targeting single health conditions, but the cost, complexity and number of options “gives too many opportunities to health care systems to say no,” said Mike Trenell, Daiser CEO. The second generation of digital health might have the answers, he said.
Researchers from the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Center are testing Digostics’ GTT@home test in children to assess if it offers a better alternative to the clinical gold-standard oral glucose tolerance test.
Glucotrack is a step closer to marketing its implantable continuous blood glucose monitor, which met primary safety endpoints in its first human trial and is pitched as a potential alternative to existing CGM systems.
The US FDA says diabetes patients who rely on their smartphones to receive critical disease-related alerts should ensure their phones are configured correctly. If not, the alerts might be missed.
During CES 2025, Medtech Insight accompanied Deloitte analysts Neal Batra and Andrew Davis to identify the biggest trends in digital health and solutions poised to transform the future of health care. Key trends included empowering consumers with actionable health data, the rising investment in specialized areas such as women’s health, and more companies pursuing regulatory clearance for health products.
Medtech Insight spoke with René Quashie, vice president of digital health at the Consumer Technology Association (CTA), about what to expect at this year’s CES show.
As part of its Home as a Health Care Hub initiative, the US FDA’s device center has unveiled an Idea Lab that includes a virtual reality experiencing offering an inside look at what is possible for patients receiving care at home utilizing the latest digital technologies.
Dexcom invests $75m in ŌURA, cementing a data-sharing partnership with the smart ring developer.
This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.
Abbott is celebrating the opening of its new manufacturing facility in Ireland for diabetes care.
The company has taken the ambitious approach of establishing a manufacturing base capable of producing millions of devices before any attempt at a regulatory submission.
Beta Bionics’ automated insulin delivery system is now pairable with Abbott’s FreeStyle Libre 3 Plus CGM.