GlobalData on MSN

Portal Diabetes’ insulin pump receives FDA breakthrough device designation

The designation supports priority engagement with the FDA as Portal Diabetes advances clinical trials and regulatory submissions.
Indianapolis Business Journal

Westfield-based company receives expedited FDA review for insulin-delivery device

The "breakthrough" designation is intended to speed development and expedite review by federal regulators, especially for critical diseases.
Engadget

All-in-one diabetes devices could take the hassle out of insulin injections

People with diabetes have more than a few hassles, particularly at meals. They not only have to measure their blood glucose levels and inject the right amount of insulin, but carry all the relevant ...
FOX8 Cleveland

LANNETT ANNOUNCES PATENT LICENSES FOR THE PEN INJECTOR DELIVERY DEVICE TO BE USED FOR ITS INSULIN GLARGINE AND INSULIN ASPART DEVELOPMENT PROGRAM

TREVOSE, Pa., Nov. 7, 2022 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an agreement with Ypsomed AG, the manufacturer and supplier of the pen injector ...
ABC 7 Chicago

FDA clears 1st device to enable automated insulin dosing for those with type 2 diabetes

WASHINGTON -- The U.S. government has cleared the way for the first medical device that enables automated insulin dosing for people with type 2 diabetes. The plastic pod, called the Omnipod 5 ...
FierceBiotech

PRESS RELEASE: Amylin Pharmaceuticals Says SYMLIN Pen-Injector Devices Use Without Mealtime Insulin Not Approvable

SAN DIEGO, Oct. 1-- Amylin Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved the SymlinPen(TM) 120 and the SymlinPen(TM) 60 pen-injector devices for ...