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Insulet wins FDA clearance for Omnipod 5 algorithm enhancements

December 4, 2025 By Sean Whooley

Insulet Omnipod 5 worn on the back of an arm

Insulet (Nasdaq:PODD) announced today that it received FDA 510(k) clearance for new enhancements to its Omnipod 5 system. The Acton, Massachusetts–based company said the updates to its tubeless, wearable automated insulin delivery patch pump’s algorithm include a new benchmark in tubeless diabetes technology with a lower, 100 mg/dL target glucose option. It also delivers a […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Technology Tagged With: FDA, Insulet

Insulet makes Omnipod 5 available with Dexcom G7 15 Day CGM

December 2, 2025 By Sean Whooley

Insulet Omnipod 5 Dexcom G7 15 Day

Insulet (Nasdaq:PODD) today announced immediate compatibility between its Omnipod 5 system and the Dexcom (Nasdaq:DXCM) G7 15 Day CGM. Acton, Massachusetts-based Insulet, which has paired its pumps with previous versions of Dexcom continuous glucose monitors (CGMs), has offered Omnipod 5 with the initial version of G7 since early 2024. However, Dexcom received FDA clearance for people […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Dexcom, Insulet

Medtronic begins full commercial rollout of MiniMed 780G with Instinct sensor made by Abbott

December 2, 2025 By Sean Whooley

Medtronic MiniMed 780G Instinct CGM made by Abbott (1) (1)

Medtronic (NYSE:MDT) today announced the full U.S. launch for its Instinct sensor, made by Abbott, paired with the MiniMed 780G pump. The medtech giant’s diabetes unit — one of the largest diabetes tech businesses in the world — won FDA clearance for its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC) earlier this year, enabling […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: abbott, Medtronic, minimed

Embecta Q4 sales fall short amid dynamic market, China hurdles

November 25, 2025 By Sean Whooley

BD Diabetes Spinoff Embecta

Embecta (Nasdaq:EMBC) today posted fourth-quarter financial results that proved mixed compared to the consensus forecast on Wall Street. Shares of EMBC remained unmoved at $14.64 apiece in pre-market trading today. The Parsippany, New Jersey-based BD Diabetes spinoff reported profits of $26.4 million. That equals 45¢ per share on sales of $264 million for the three […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: embecta

PreEvnt brings non-invasive glucose alert device to clinical trials

November 24, 2025 By Sean Whooley

PreEvnt Isaac blood glucose alert device

PreEvnt announced today that its Isaac non-invasive glucose monitoring system has entered clinical trials. Under the direction of Dr. Mangilal Agarwal, the device entered trials at Indiana University, Indianapolis. The study marks a step forward in validating Isaac’s potential as a tool for managing diabetes through breath-based measurements. The current phase of research includes adolescents […]

Filed Under: Clinical Trials, Diabetes, Featured, Patient Monitoring, Technology Tagged With: PreEvnt

Abbott initiates correction for FreeStyle Libre 3, Libre 3 Plus CGMs after reports of deaths

November 24, 2025 By Sean Whooley

Abbott FreeStyle Libre 3 sensor pennies CGM diabetes

Abbott (NYSE:ABT) announced today that it issued a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors in the U.S. This correction comes as a result of an issue that led to hundreds of severe adverse events, including seven deaths. Abbott — one of the largest diabetes tech companies in the world —  […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Recalls, Technology Tagged With: abbott

Insulet CEO Ashley McEvoy lays out plans for Omnipod 6, innovation roadmap

November 20, 2025 By Sean Whooley

Ashley McEvoy Insulet CEO (1)

Insulet (Nasdaq:PODD) today hosted its Investor Day, led by President and CEO Ashley McEvoy, laying out the future for the insulin pump maker. McEvoy, who assumed the corner office six months ago, has recently spoken about the company’s use of artificial intelligence to advance its automated insulin delivery (AID) offerings, while competition continues to heat […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Technology Tagged With: Insulet

Insulet to launch next-gen Omnipod 6 in 2027, outlines plans for fully closed loop pump for type 2

November 20, 2025 By Sean Whooley

Insulet Omnipod 5 in Pool

Insulet (Nasdaq:PODD) today revealed plans for its innovation pipeline, which includes the next-generation Omnipod 6 system. At the company’s Investor Day event, held at its Acton, Massachusetts headquarters, President and CEO Ashley McEvoy laid out the company’s innovation roadmap. That includes updates to the current-generation Omnipod 5 platform, the new Omnipod 6 and a new, […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Technology Tagged With: Insulet

Dexcom to launch G7 15 Day CGM next month

November 20, 2025 By Sean Whooley

Dexcom G7 15 Day CGM in use (1)

Dexcom (NSDQ:DXCM) announced today that it plans to launch its G7 15 Day continuous glucose monitor (CGM) in the U.S. next month. The San Diego–based company plans to make the CGM available for people over the age of 18 with diabetes on Dec. 1. Initially, the company plans to make the sensor available for users […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Dexcom

Dexcom wins FDA nod for smart CGM-integrated basal dosing for type 2 diabetes

November 19, 2025 By Sean Whooley

Dexcom Smart Basal insulin dosing type 2 diabetes with G7 CGM

Dexcom (NSDQ:DXCM) announced today that the FDA cleared its Smart Basal CGM-integrated basal insulin dosing optimizer. The continuous glucose monitor (CGM)-based offering received clearance for adults with type 2 diabetes on glargine U-100 long-acting insulin therapy. San Diego-based Dexcom says it marks the first and only CGM-integrated basal dosing optimizer cleared for type 2 diabetes. […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: Dexcom, FDA

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