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Sean Whooley

How Bigfoot Biomedical plans to take diabetes management forward

January 27, 2022 By Sean Whooley

Bigfoot Biomedical smart insulin pen cap

For close to 20 years, Jeffrey Brewer has focused on finding ways to support insulin delivery and manage diabetes. Initially an entrepreneur, Brewer got involved with the Juvenile Diabetes Research Foundation (JDRF) and the Artificial Pancreas Project for developing a closed-loop insulin delivery system after his son was diagnosed with type 1 diabetes. After spending […]

Filed Under: Auto-injectors, Big Data, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Research & Development Tagged With: abbott, Bigfoot Biomedical

Stevanato Group extends licensing agreement with Haselmeier for pen injector tech

January 26, 2022 By Sean Whooley

Stevanato Group Alina pen injector

Stevanato Group (NYSE:STVN) announced today that it signed an extension to a licensing agreement with Haselmeier over its pen injector technology. Piombino Dese, Italy-based Stevanato Group’s license extension gives the company exclusivity to offer the Axis-D pen injector technology in support of a broader range of drugs for its biopharma customers beyond diabetes, including areas […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured Tagged With: haselmeier, Stevanato Group

Glytec enters insulin management partnership with Nebraska Medicine

January 25, 2022 By Sean Whooley

Glytec

Glytec announced today that it entered into a strategic partnership with Nebraska Medicine to advance patient safety and innovation in insulin management. Under the agreement, Nebraska Medicine will implement Glytec’s eGlycemic Management System (eGMS) across all 800 beds at its two hospitals: the Nebraska Medical Center and Bellevue Medical Center. The agreement also includes collaboration […]

Filed Under: Auto-injectors, Big Data, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Research & Development Tagged With: Glytec

Lyra Therapuetics initiates Phase 3 trial for chronic rhinosinusitis treatment

January 24, 2022 By Sean Whooley

Lyra Therapeutics LYR-210

Lyra Therapeutics (NSDQ:LYRA) announced today that it initiated the Phase 3 Enlighten I trial for its LYR-210 treatment. Watertown, Massachusetts-based Lyra’s Phase 3 Enlighten I clinical trial will evaluate LYR-210, delivered through Lyra’s proprietary XTreo drug-eluting implant, in adult, surgically naïve chronic rhinosinusitis (CRS) patients. The company designed LYR-210 for delivery in a brief, non-invasive, […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Otolaryngology Ear, Nose & Throat, Pharmaceuticals Tagged With: Lyra Therapeutics

MIT team working on all-in-one diabetes management devices

January 20, 2022 By Sean Whooley

MIT Insulin Dosing device diabetes

MIT researchers are touting a platform aimed at helping patients maintain healthy glucose levels by streamlining the diabetes management process. The MIT researchers say it’s hard for people with diabetes to maintain a treatment regimen. Typically at every meal, they need to estimate carbohydrate content, draw blood to measure blood glucose levels, and calculate the […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Research & Development Tagged With: Diabetes, mit

Fractyl Health touts preliminary data from diabetes reversal study

January 20, 2022 By Sean Whooley

This is the logo of Fractyl Health.

Fractyl Health this week announced encouraging interim feasibility data from its diabetes reversal technology study. Lexington, Massachusetts–based Fractyl’s Revita-T2Di long-term open-label cohort assessed eight patients followed through at least four weeks having been treated. The company’s Revita system resurfaces the upper intestine lining (duodenal mucosa) to treat metabolic disease in patients with insulin-treated type 2 […]

Filed Under: Business/Financial News, Clinical Trials, Diabetes, Featured, Surgical Tagged With: Fractyl Health, fractyllaboratories

FDA grants IDE approval for Capillary Biomedical’s 7-day-wear infusion set

January 19, 2022 By Sean Whooley

Capillary Biomedical

Capillary Biomedical announced today that it received FDA investigational device exemption (IDE) for its SteadiFlow infusion technology. Irvine, California-based Capillary Biomedical designed its new SteadiFlow seven-day-wear infusion set technology to significantly extend patient wear time to a week and maintain insulin stability. The SteadiSet infusion set, powered by the SteadiFlow technology platform, features an integrated […]

Filed Under: Auto-injectors, Business/Financial News, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: capillarybiomedical, FDA

Ahead of G7 launch, Dexcom CEO plans for ‘more activity than we’ve ever seen’ in 2022

January 14, 2022 By Sean Whooley

Dexcom G7 Wearable Top (1)

With a major product approval and launch in its sights, Dexcom prepares for a big year in 2022. Across 2021, Dexcom (NSDQ:DXCM) took several steps forward. The company touted its next-generation G7 continuous glucose monitor (CGM) and announced a significant regulatory nod and partnership for real-time application programming interfaces (APIs), to list a couple. As […]

Filed Under: Auto-injectors, Big Data, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Wall Street Beat Tagged With: Dexcom, Garmin, Insulet, Medtronic

FDA grants new drug approval to Glenmark’s rhinitis-treating nasal spray

January 14, 2022 By Sean Whooley

Glenmark

Glenmark Pharmaceuticals announced today that it received FDA approval for a new drug application (NDA) for Ryaltrais. Ryaltris, a fixed-dosed, prescription drug product nasal spray treats symptoms of seasonal allergic rhinitis in adults and pediatric patients over 12 years of age in the U.S. Glenmark’s fully owned subsidiary, Glenmark Specialty S.A. (Switzerland), received the NDA […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Respiratory Tagged With: FDA, Glenmark Pharmaceuticals

Fort HealthCare, Ivenix partner on infusion safety effort with smart pump

January 13, 2022 By Sean Whooley

Ivenix logo

Ivenix announced today that it successfully implemented its smart infusion pump at the Fort HealthCare hospital in Wisconsin. Boston-based Ivenix designed its Ivenix Infusion System, a combination of a large-volume infusion pump and infusion management software, to offer unique capabilities within the infusion therapy market, with pumps deployed at Fort HealthCare set to connect with […]

Filed Under: Auto-injectors, Business/Financial News, Drug-Device Combinations, Featured, Hospital Care Tagged With: Fort HealthCare, Ivenix

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