Apr 25,2023

Insulet Announces FDA Clearance of Omnipod GO™, a First-of-its-Kind Basal-Only Insulin Pod, Further Simplifying Life for People with Type 2 Diabetes

Insulet Corporation announced the FDA clearance of its latest innovation, Omnipod GO™, an insulin delivery device cleared for use for people with type 2 diabetes age 18 or older who would typically take daily injections of long-acting insulin. Omnipod GO is a standalone, wearable, insulin delivery system that provides a fixed rate of continuous rapid-acting insulin for 72 hours. It has been cleared for use with the following U-100 insulins: NovoLog®, Fiasp®, Humalog®, Admelog®, and Lyumjev®. The product was developed to serve people with type 2 diabetes earlier in their treatment journey by starting them on Pod therapy for their insulin delivery, rather than daily injections. Insulet plans to commercialize Omnipod GO in the United States in 2024.

REGULATORY FDA

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Apr 21,2023

FDA Approves Medtronic MiniMed™ 780G System - World's First Insulin Pump with Meal Detection Technology* Featuring 5-Minute Auto Corrections†§

Medtronic announced U.S. FDA approval of its MiniMed™ 780G system with the Guardian™ 4 sensor requiring no fingersticks while in SmartGuard™ technology. The system provides insulin to help account for when users occasionally forget to bolus or underestimates the number of carbs in their meal. This milestone marks the approval of the only system with meal detection technology that provides automatic adjustments and corrections to sugar levels every 5 minutes

REGULATORY FDA

#closed loop

#insulin pump

#cgm

View Analyst & Ambassador Comments
Go to original news
Apr 14,2023

FDA CLEARS READER FOR ABBOTT'S FREESTYLE LIBRE® 3 SYSTEM

Abbott today announced that the U.S. FDA has cleared a reader for its FreeStyle Libre® 3 integrated continuous glucose monitoring (iCGM) system. With the FDA's clearance of a standalone reader, Abbott is working to get the FreeStyle Libre 3 system added to Medicare's list of covered systems as soon as possible.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
Jun 30,2017

Owise Receives CE Mark Class I Medical Device Status

OWise was CE-marked to comply with the European regulatory standards for safety and usage on the 7th of May, 2014. “It is for us of prime importance that patients are well supported throughout their treatment, which is why we wanted to make sure that OWise is safe to use and fit for purpose.” – said Dr. Anne Bruinvels, founder of OWise.

REGULATORY CE MARK

#mobile app

View Analyst & Ambassador Comments
Go to original news
Feb 09,2023

Ibex's Galen™ Prostate Becomes First Standalone AI-Powered Cancer Diagnostics Solution to Obtain CE Mark Under the IVDR

Ibex Medical Analytics today announced that Galen™ Prostate is now CE marked under the In Vitro Diagnostic Medical Devices Regulation (IVDR) for supporting pathologists in primary diagnosis of prostate biopsies. Galen Prostate is the first standalone AI-based cancer diagnostics product of its kind certified under the IVDR. IVDR is the new regulatory standard set by the European Union, replacing the previous In Vitro Diagnostic Medical Device Directive (IVDD). During 2023, Ibex plans to migrate additional products, including its Galen Breast and Galen Gastric solutions, under the IVDR certificate. Galen Prostate uses AI to analyze biopsies ahead of pathologists' review, providing them with diagnostic insights to guide their diagnosis.

REGULATORY CE MARK

#ai/software

View Analyst & Ambassador Comments
Go to original news
Mar 02,2023

Bigfoot Biomedical Receives FDA Clearance for Bigfoot Unity® Android App for People Living with Insulin-Requiring Diabetes

Bigfoot Biomedical today announced the U.S. Food and Drug Administration has issued 510(k) clearance for the Android version of the Bigfoot Unity® Mobile App, a necessary component of the Bigfoot Unity® Diabetes Management System. The Bigfoot Unity System is the first and only FDA-cleared smart injection system that turns continuous glucose management (CGM) data into insulin dosing advice displayed right on the pen cap for people using multiple daily injection therapy. “Most Bigfoot Unity users live with type 2 diabetes and are part of a demographic that is even more likely to use Android devices than the general U.S. population," said Jeffrey Brewer, CEO of Bigfoot Biomedical.

REGULATORY FDA

#mobile app

View Analyst & Ambassador Comments
Go to original news
Mar 06,2023 TOP STORY

U.S. FDA Clears Abbott's FreeStyle Libre® 2 and FreeStyle Libre® 3 Sensors for Integration with Automated Insulin Delivery Systems

Abbott today announced that the U.S. Food and Drug Administration has cleared its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring system sensors for integration with automated insulin delivery (AID) systems. Abbott modified the sensors to enable integration with AID systems. AID systems help people manage daily diabetes care by automatically adjusting and administering the insulin delivered by an insulin pump based on real-time glucose data from their FreeStyle Libre 2 or FreeStyle Libre 3 sensors. The company is partnering with Insulet and Tandem for future integrations in multiple countries, including the U.S. Outside the U.S., Abbott's FreeStyle Libre 3 sensor is already authorized to work with the mylife™ Loop solution from Ypsomed and CamDiab in Germany, with additional launches in the UK, Switzerland and the Netherlands planned for the first half of this year.

REGULATORY FDA

#cgm

#closed loop

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Feb 28,2023

Theranica’s Nerivio® Cleared by FDA for Preventive Treatment of Migraine

Theranica today announced that the Nerivio® prescription wearable recently received Food and Drug Administration (FDA) clearance as a dual-use acute and preventive treatment for migraine with or without aura in people 12 years of age or older. In a randomized placebo-controlled study, the drug-free Nerivio, used every other day, demonstrated significant reduction in monthly migraine days and other prevention endpoints.

REGULATORY FDA

#pdt

#connected device

#mobile app

View Analyst & Ambassador Comments
Go to original news
Feb 20,2023

Innovation Zed Announces CE Mark of New Technology InsulCheck DOSE: An Add-on Device That Automatically Logs the Time and Dialled Dosage for Insulin Pen Users

Innovation Zed, an Irish R&D company specialising in the design, development and manufacturing of medical technologies, announced today it has secured a CE Mark for the InsulCheck DOSE add-on device. InsulCheck DOSE is a single-unit add-on device for pen injectors that automatically captures dose value dialled, injection event time stamp and temperature as well as mounting and unmounting events. With InsulCheck DOSE, real-time injection event data are logged and sent automatically to a compatible display device.

REGULATORY CE MARK

#insulin pen

View Analyst & Ambassador Comments
Go to original news
Feb 03,2023

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. Tidepool designed Tidepool Loop for the management of type 1 diabetes in people with diabetes six years of age or older. It has compatibility with the Apple Watch, according to the company’s website. According to a news release, the algorithm works with compatible integrated CGMs and alternate controller-enabled (ACE) pumps.

REGULATORY FDA

#closed loop

View Analyst & Ambassador Comments
Go to original news
Subscribe to REGULATORY