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 […]
Dexcom to announce U.S. G7 launch in Super Bowl commercial with 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 […]
Glooko picks up security certification for diabetes patient management platform
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 […]
Tidepool Loop automated insulin delivery system wins FDA clearance
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 […]
Know Labs inks partnerships to accelerate progress toward FDA clearance for 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 […]
Vero Biotech wins FDA approval for inhaled nitric oxide delivery with anesthesia in the OR
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 […]
How Embecta started strong and what’s ahead for the BD diabetes spinoff
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. […]
Owen Mumford wins Pharmapack award for 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 […]
Phillips-Medisize unveils new disposable injector pen
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 […]
Fractyl Health ‘encouraged’ by results from diabetes reversal study
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 […]
