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 ...
Nasdaq

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 ...
FierceBiotech

FDA issues Class I recall label to Insulet’s Omnipod Android app over incorrect bolus calculations

The FDA has handed down a Class I recall label, the agency’s most serious, to a now-corrected software issue that could have resulted in delivering ten times the desired insulin dose from Insulet’s ...
MobiHealthNews

Insulet gets FDA nod to commercialize Omnipod Dash Insulin Management System

Billerica, Massachusetts-based Insulet Corporation, maker of the OmniPod Insulin pump, has just announced that it received the FDA clearance to commercialize its latest product the Omnipod Dash ...
FierceBiotech

Insulet's power problems grow with FDA battery recall, Omnipod 5 charger notice

Just a few weeks after beginning a voluntary recall of the remote-control devices used with some of its insulin pumps—and warning that the safety action would take a multimillion-dollar hit to its ...
USA Today

Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod® 5 Controller

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 ...
Business Wire

Insulet to Present Extended Real-World Evidence and Best Practices for Optimizing Care with Omnipod ® 5

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 ...