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Sean Whooley

Dexcom partners with Green Shield, Health Depot on digital diabetes management service

December 12, 2022 By Sean Whooley

Dexcom G6 in action

Dexcom (Nasdaq:DXCM) announced today that it partnered with Green Shield and The Health Depot to expand access to the Dexcom G6. The partnership offers Green Shield plan members convenient access to the G6 real-time continuous glucose monitor (rtCGM). It combines this access with virtual diabetes coaching support. Green Shield plan members eligible for G6 coverage […]

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

Boston Scientific to acquire majority stake in interventional tech developer Acotec

December 12, 2022 By Sean Whooley

Boston Scientific

Boston Scientific (NYSE:BSX) announced that it intends to make a partial offer to acquire a majority stake in Acotec. Marlborough, Massachusetts-based Boston Scientific’s offer could add up to a maximum of 65% of Acotec’s shares. Its proposed price totals HK$20 per share. That amounts to approximately $523 million for the 65% stake at current exchange […]

Filed Under: Business/Financial News, Drug-Device Combinations, Mergers & Acquisitions, Vascular, Wall Street Beat Tagged With: Acotec, Boston Scientific

Smiths Medical issues urgent device correction for some CADD infusion pumps

December 12, 2022 By Sean Whooley

Smiths Medical

Smiths Medical today issued an urgent medical device correction letter to inform customers of potential issues with its CADD infusion system. The company — which ICU Medical acquired in January for $2.35 billion — identified two potential issues with the infusion sets. They relate to the potential lack of delivery or underdelivery and false no […]

Filed Under: Drug-Device Combinations, Featured, Recalls, Regulatory/Compliance Tagged With: ICU Medical, Smiths Medical

NIH funds Illinois Tech project using machine learning to fully automate insulin delivery

December 9, 2022 By Sean Whooley

Illinois Tech artificial pancreas machine learning insulin delivery diabetes

Researchers at Illinois Institute of Technology received $1.2 million from the NIH to develop a machine learning system for an artificial pancreas’ insulin delivery. Chemical engineering professor Ali Cinar leads the project to ease the burden on those with type 1 diabetes. NIH funding covers four years for developing the machine learning system. The researchers […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Funding Roundup, Patient Monitoring, Technology Tagged With: Illinois Institute of Technology, Illinois Tech, National Institutes of Health

Eli Lilly discontinues Ypsomed collaboration to pursue its own U.S. insulin pump offering

December 9, 2022 By Sean Whooley

Ypsomed Eli Lilly

Ypsomed announced today that Eli Lilly (NYSE:LLY) elected to stop their joint project to enter the U.S. insulin pump market. In November 2020, the companies entered into a commercialization agreement. The agreement entailed registering and commercializing Ypsomed’s YpsoPump under Lilly’s branding in the U.S. Ypsomed said that, over the past two years, it customized its […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Technology Tagged With: Eli Lilly, Eli Lilly & Co., Ypsomed

FDA accepts NDA for intranasal epinephrine from ARS Pharmaceuticals

December 8, 2022 By Sean Whooley

ARS pharmaceuticals neffy neurelis

ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription […]

Filed Under: Business/Financial News, Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: arspharmaceuticals, Neurelis Inc.

FDA clears Dexcom G7 next-gen CGM

December 8, 2022 By Sean Whooley

Dexcom G7

Dexcom (Nasdaq:DXCM) announced today that the FDA cleared the next-generation Dexcom G7 continuous glucose monitoring (CGM) system. FDA clearance for the highly anticipated device covers people with all types of diabetes aged 2 years and older. San Diego-based Dexcom’s device features a 60% size reduction from the previous generation, the G6. It offers a 30-minute […]

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

FDA clears Mallya smart insulin pen device from Biocorp

December 7, 2022 By Sean Whooley

Biocorp Mallya smart insulin pen Novo Nordisk flextouch pen

Biocorp announced today that it received FDA 510(k) clearance to market its Mallya smart medical device that connects insulin pens. Mallya, a smart sensor, attaches directly to insulin pen injectors to make them connected devices. It automatically collects nad records key treatment information and transmits it to a dedicated digital application. That data includes selected […]

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

Cell Pouch System developer Sernova announces CEO transition

December 6, 2022 By Sean Whooley

Sernova Cell Pouch System Type 1 Diabetes

Sernova announced today that, as part of a planned leadership succession process, Dr. Philip Toleikis will transition out of the CEO role. Toleikis spent 13 years leading the Cell Pouch System developer as president and CEO. He remains an executive at the company as the planned transition moves him to chief technology officer (CTO). Additionally, […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Implants, Personnel Tagged With: Personnel, Personnel Moves, Sernova Inc

Vaxxas raises $23M for needle-free drug delivery tech

December 5, 2022 By Sean Whooley

Vaxxas micropatch vaccine COVID-19

Vaxxas announced today that it completed a financing round that brings in $23 million (A$34 million) in new funds. Existing investors OneVentures and UniQuest led the round. New investors, including members of the Vaxxas board and management team, along with individual investors, participated. The company earmarked proceeds to advance its clinical programs, including its needle-free […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Pharmaceuticals Tagged With: Vaxxas

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