Tag: Diabetes
Sequel’s twiist approved for adults with inulin-treated Type 2 diabetes
October 20, 2026HME News Staff
MANCHESTER, N.H. – The twiist Automated Insulin Delivery (AID) System has been cleared by the U.S. Food and Drug Administration (FDA) for use in adults over 18 with insulin-treated Type 2 diabetes. The clearance follows twiist's national launch for Type 1 diabetes in March 2026. "For many adults living with Type 2 diabetes, insulin therapy can feel like one more thing to manage in an already busy life," said Sequel CEO and Co-Founder Alan Lotvin, MD. "At Sequel, we believe...
Sava receives $36M in funding, partners with Ascensia
October 14, 2026HME News Staff
LONDON – Sava Technologies has received $36 million in Series B funding, alongside an agreement appointing Ascensia, a subsidiary of PHC Holdings Corp., as its commercialization and distribution partner, starting off in Europe. Founded in 2019, Sava has developed a wearable built on its proprietary microsensor technology that measures molecules just beneath the skin, painlessly and continuously. While starting with glucose, the platform is designed to track other biomarkers, too, opening the...
In brief: PAP recall, indie outlook, OTC sensor, Kalogon hire
October 6, 2026HME News Staff
WASHINGTON – BMC Medical retrospectively reported to the U.S. Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP devices (model LG3600) distributed in the United States due to a firmware defect, the agency has reported.
The FDA has classified it as a Class I recall (FDA Recall Number: Z-2979-2026).
BMC has identified that the firmware version G3-2.00.76 with configuration G3 A20-31.cfg that is installed on these Luna devices contained a debug code. The company conducted...
Biolinq glucose sensor receives clearance for OTC use
October 5, 2026HME News Staff
SAN DIEGO – Biolinq Incorporated has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter (OTC) use of Biolinq Shine, the company’s needle-free glucose sensor designed to provide a simple, intuitive view of glucose, activity and sleep information in a single device with autonomous operation. The clearance expands access to Biolinq Shine without a prescription, marking the company’s latest regulatory milestone following FDA...
Dexcom reports on access, attitudes to diabetes technology
September 29, 2026HME News Staff
MILAN – A majority of health care providers (HCPs) recognize continuous glucose monitoring (CGM) as essential to Type 2 diabetes management, according to a new report published by Dexcom ahead of the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan Sept. 28-Oct. 2.
Eighty-nine percent of HCPs believe CGM helps them assess treatment adherence between appointments, and more than half of current CGM users report they have followed their treatment plan...
CGM could lower risk of dying for people with diabetes, according to new analysis
September 28, 2026HME News Staff
YARMOUTH, Maine – People with Type 2 diabetes on basal insulin who are starting continuous glucose monitoring (CGM) had a 44% lower risk of dying from any cause after one year compared with those who did not use CGM, according to an analysis of patient data being presented at the Annual Meeting of The European Association for the Study of Diabetes (EASD) in Milan Sept. 28-Oct. 2. The risk was 35% lower after two years, according to the analysis. Researchers say the analysis provides the first...
Medically Modern builds scale through practice partnerships, payer access
September 25, 2026HME News Staff
NEW YORK – Medically Modern is in growth mode with a new model that uses its insurance expertise and customized technology to help physicians better manage their diabetes patients, says founder and CEO Corey Deutsch.
Medically Modern recently announced a new partnership with an independent, multi-location endocrinology practice in Northern Virginia to manage prior authorization and fulfillment for its continuous glucose monitor (CGM) and insulin pump referrals.
‘We speak fluent...
Medically Modern partners with endocrinology practice
September 14, 2026HME News Staff
NEW YORK – Medically Modern has a new partnership with an independent, multi-location endocrinology practice in Northern Virginia to manage prior authorization and fulfillment for its continuous glucose monitor (CGM) and insulin pump referrals. The company says the partnership gives the practice’s care team real-time visibility into every referred patient’s prescribed supplies. "We pivoted into this partnership strategy after hearing the same thing from providers over and over:...
MiniMed touts ‘excellent start’ to fiscal year
September 1, 2026HME News Staff
NORTHRIDGE, Calif. – MiniMed reported global net sales of $843 million for the first quarter of fiscal year 2027, growing 17% as reported and 16% organic. The company says U.S. net sales were $240 million, growing 13% as reported and organic. “MiniMed delivered an excellent start to our fiscal year, with accelerating U.S. growth, continued double-digit international growth, and strong execution across our innovation pipeline," said MiniMed CEO Que Dallara. "The U.S. launch of...
Abbott gets FDA clearance for dual sensing technology
August 27, 2026HME News Staff
ABBOTT PARK, Ill. – Abbott has received U.S. Food and Drug Administration (FDA) authorization of its Libre Duo 10 Day system, a dual glucose ketone sensing technology. The new biowearable is designed to alert people living with diabetes of rising ketones that can lead to a diabetic ketoacidosis (DKA) emergency, a serious health complication for people with diabetes. "As a physician, I see how quickly DKA can develop—and how often early warning signs or opportunities to measure...