MobiHealthNews

FDA identifies Insulet Omnipod DASH battery recall as Class I

The FDA posted a notice saying the recall of Insulet's Omnipod DASH Insulin Management System Personal Diabetes Manager is a Class I, the most serious recall indicating the devices could cause serious ...
Monthly Prescribing Reference

FDA Clears Omnipod 5 Tubeless Insulin System for Diabetes Management

The Omnipod 5 System consists of a tubeless wearable Pod, the Omnipod 5 mobile app, and the Dexcom G6 Continuous Glucose Monitoring System. The Food and Drug Administration (FDA) has cleared the ...
Monthly Prescribing Reference

Omnipod 5 Tubeless Automated Insulin Delivery System Cleared for Younger Kids

The clearance was based on data from a single-arm multicenter clinical trial that evaluated the Omnipod 5 system in 80 children aged 2 to 5.9 years with type 1 diabetes. The Food and Drug ...
Business Wire

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

ACTON, Mass.--(BUSINESS WIRE)--Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod ® brand of products, today announced ...
Business Wire

Insulet Issued Voluntary Medical Device Correction for Omnipod DASH® Personal Diabetes Manager on October 17, 2022

ACTON, Mass.--(BUSINESS WIRE)--Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers ...