Diabetic Care

New rule in effect Jan. 1 follows OIG call for CMS to use competitive bidding to adjust payments for continuous glucose monitors after finding that Medicare was paying above supplier costs and retail prices.

US Medicare payments for CGMs and supplies in the year to June 2023 exceeded suppliers’ acquisition costs by $377m, says new OIG report

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

Brain-computer interfaces advance toward trials and commercialization, Oura pushes for FDA-cleared blood pressure monitoring, and regulators weigh AI’s expanding role in mental health and diagnostics amid rising safety concerns.

Tandem Diabetes Care is positioning for growth in 2026 with the launch of its Mobi Tubeless pump following FDA clearance of its Android-compatible Mobi app while navigating multiple recalls during what CEO John Sheridan called a transformative year.

Viome Life Sciences accelerates its push into clinical diagnostics with studies in colorectal cancer and a major partnership with Microsoft to scale its molecular data analysis platform. Viome leverages RNA analysis and AI to detect disease at the molecular level and personalize preventive health.

Wearables innovator Oura has launched a profile study aimed at helping the company secure FDA clearance for a blood pressure feature for its smart ring. Study participants will answer questions while wearing the ring, which the company plans to use to support the feature’s efficacy.

Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.

Though the advance of remote medical device technology allows for better at-home care, it comes with challenges and risks, says AdvaMed, which has published a safety bulletin guiding stakeholders on the operation of remote devices.

Fresh off de novo clearance, Biolinq plans to launch its needle-free CGM for type 2 diabetes not on insulin in early 2026. Pricing has not been disclosed, but “won’t be too far apart” over rivals Abbott’s Lingo and Dexcom’s Stelo CGMs, CEO Rich Yang said.

Dexcom has endured recalls, layoffs and leadership change, but interim CEO Jake Leach said the company remains committed to innovating next-gen devices.

Rapid Nexus hopes its regenerative wound-healing system can ease the burden of diabetic foot ulcers and amputations. Backed by early clinical data and $3.8m in seed funding, the start-up is targeting the VA as a launchpad into a $6.5bn US market, with FDA clearance expected later this year.

Glooko's buyout of Monarch Medical Technologies’ EndoTool extends its diabetes management platform into hospitals in 2026, a move CEO Mike Alvarez says could unlock a $1bn market as CMS ramps up electronic quality measure reporting.

Sava Technologies has developed a CGM that uses microneedles to accurately measure glucose levels for up to 10 days without finger-prick calibration. The company raised £14.2m in Series A funding to establish in-house manufacturing for faster production.

Tandem Diabetes Care initiated a recall last month of several t:slim X2 insulin pumps due to a “malfunction 16” error that can cause the pumps to shut down. The problem is triggered by wiring within the device speaker.

Dutch insulin pump maker ViCentra secured $85m to scale European manufacturing, preparing for the 2026 launch of its thinner, lighter Kaleido 2 pump and push into US market. CEO Tom Arnold said the pump has more than 3,500 users in Europe and expects “tens of thousands” in the next 18 months.

Roche Diagnostics, Intuitive Surgical, Abbott and Edwards Lifesciences all acknowledge tariff headwinds, but stress preparedness, resilience and mitigation. Below is look at how management framed the impact in Q1 vs Q2 earnings calls.

Signos links users to Dexcom’s Stelo for glucose readings and historic trends. The app is available in iOS and Android from the firm’s website, where it’s priced at $139 for three-month plan and $129 for a two-month plan, or online app stores.

Medtronic beat first-quarter revenue and EPS estimates, raised guidance, and added two board members and special committees as Elliott takes a stake.

Luna Health has raised $23.6m in Series A funding to support regulatory submissions, clinical studies and manufacturing for its insulin patch pump.