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Sean Whooley

Fractyl Health launches diabetes reversal treatment in Germany

February 7, 2023 By Sean Whooley

This is the logo of Fractyl Health.

Fractyl Health announced today that it commercially launched its Revita DMR system for diabetes reversal in Germany. Revita, an endoscopic procedural therapy, remodels the duodenal lining through hydrothermal ablation. This tackles a root cause of type 2 diabetes. Revita holds CE mark approval in Europe and established reimbursement in Germany recently. Lexington, Massachusetts-based Fractyl performed […]

Filed Under: Business/Financial News, Diabetes, Surgical Tagged With: Fractyl Health

Dexcom to announce U.S. G7 launch in Super Bowl commercial with Nick Jonas

February 7, 2023 By Sean Whooley

Dexcom G7 CGM Super Bowl Commercial Nick Jonas

Dexcom (Nasdaq:DXCM) today unveiled its upcoming Super Bowl commercial that announces the U.S. launch of its next-generation Dexcom G7 CGM. The ad, set to run during the second quarter of Super Bowl LVII on Feb. 12, features musician, actor and philanthropist Nick Jonas. Jonas lives with type 1 diabetes and uses Dexcom’s continuous glucose monitors […]

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

Glooko picks up security certification for diabetes patient management platform

February 6, 2023 By Sean Whooley

Glooko Logo

Glooko announced today that it received ISO 27001 certification for its data management and remote patient monitoring platforms. Palo Alto, California-based Glooko develops remote patient monitoring and chronic care management products. These include data management technologies for insulin delivery devices. ISO 27001, an international compliance framework, serves as the international security standard for protecting customer […]

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

Tidepool Loop automated insulin delivery system wins FDA clearance

February 3, 2023 By Sean Whooley

Tidepool Loop automated insulin delivery software

Tidepool announced recently that the FDA cleared its Tidepool Loop, a “do-it-yourself,” (DIY) automated insulin delivery (AID) system. Palo Alto, California-based Tidepool is a non-profit diabetes data management group. It created the hybrid, closed-loop AID app for compatibility with multiple insulin pumps and continuous glucose monitors. The company announced collaborations in the past that include […]

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

Know Labs inks partnerships to accelerate progress toward FDA clearance for glucose monitor

February 3, 2023 By Sean Whooley

Know Labs KnowU Uband non-invasive glucose monitor

Know Labs (NYSE:KNW) announced that it entered into a series of strategic partnerships as it looks to move toward a major regulatory nod. Seattle-based Know Labs develops the Bio-RFID technology. It uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. This technology integrates into wearable, mobile or bench-top […]

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

Vero Biotech wins FDA approval for inhaled nitric oxide delivery with anesthesia in the OR

February 3, 2023 By Sean Whooley

Vero Biotech Genosyl inhaled nitric oxide system

Vero Biotech announced that the FDA approved its second-generation Genosyl system for use with rebreathing anesthesia in the operating room setting. Atlanta-based Vero Biotech designed Genosyl for inhaled nitric oxide (iNO) delivery. This approval covers the second-generation Genosyl device. The third-generation device — which recently received FDA approval — has not yet been tested with […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Hospital Care Tagged With: Vero Biotech

How Embecta started strong and what’s ahead for the BD diabetes spinoff

February 2, 2023 By Sean Whooley

Embecta CEO Devdatt Dev Kurdikar headshot

Ten months after spinning off from BD, Embecta CEO Dev Kurdikar lays out what the future holds for the diabetes technology company. When Embecta became a standalone company in April 2022, CFO Jake Elguicze said he felt it was “uniquely positioned.” As a pure-play diabetes technology developer, its beginning phase hardly mirrors a normal startup. […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Research & Development, Technology Tagged With: BD, embecta

Owen Mumford wins Pharmapack award for UniSafe auto-injector

February 1, 2023 By Sean Whooley

Owen Mumford Pharmaceutical Services UniSafe auto-injector

Pharmapack Europe today announced that Owen Mumford Pharmaceutical Services received one of its 2023 Pharmapack Awards. The company received recognition in the “Drug Delivery Innovation” category for its UniSafe reusable, connected auto-injector. Woodstock, United Kingdom-based Owen Mumford designed UniSafe as a companion device for its UniSafe 1mL safety syringes. These devices deliver subcutaneous medication. UniSafe […]

Filed Under: Auto-injectors, Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: Owen Mumford

Phillips-Medisize unveils new disposable injector pen

February 1, 2023 By Sean Whooley

Phillips-Medisize disposable injector Pen (1)

Phillips-Medisize, a Molex company, announced today that it expanded its product portfolio with a new disposable pen injector. Hudson, Wisconsin-based Phillips-Medisize designed the new injector for high-volume manufacturing. It intends to offer pharmaceutical companies a familiar, competitive pen injector for faster, more efficient and cost-effective market entry. The company plans to display the pen at […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: Molex, Phillips-Medisize

Fractyl Health ‘encouraged’ by results from diabetes reversal study

January 31, 2023 By Sean Whooley

This is the logo of Fractyl Health.

Fractyl Health announced today that six-month data from a study of its diabetes reversal tech demonstrated improvements in glucose control. Interim data came from the human clinical experience in Fractyl’s Revita-T2Di long-term, open-label cohort. Revita, a procedure that remodels the duodenal lining via hydrothermal ablation, has FDA breakthrough device designation. The FDA approved an investigational […]

Filed Under: Clinical Trials, Diabetes, Featured Tagged With: Fractyl Health

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