The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...

Two years ago, Eli Lilly started working with Dexcom to ... in pen- and pump-based insulin systems that form the basis of the drugmaker’s personalised diabetes management system.

Insulet (Nasdaq:PODD) announced today that it made its Omnipod 5 automated insulin delivery system available in several new ...

Sales of Beta Bionics insulin pumps spiked 145% in the fourth quarter behind solid new patient starts. Elsewhere, former Masimo exec Jon Coleman joined Dexcom, and Sibionics’ CGM earned the CE mark.

Investors with a lot of money to spend have taken a bullish stance on DexCom DXCM ... company is evolving its CGM systems to provide integration with insulin pumps from Insulet and Tandem for ...

and Mesa, Ariz. related to concerns about manufacturing processes and quality management systems. The FDA cited issues with DexCom's response to prior inspection findings, known as Form 483 ...

Medical device companies presented new data this week at the Advanced Technologies & Treatments for Diabetes conference.

Dexcom said the warning letter, which the FDA has yet to publish, describes non-conformities in the manufacturing processes and quality management systems at the two facilities. The company does ...