Replacing Finger Stick? DexCom Says Its Latest CGM Data Is A Key Step
This article was originally published in The Pink Sheet Daily
Continuous glucose monitor firm DexCom has defined 10% accuracy compared to a lab reference as the crucial target to support its monitors as outright replacements for patient self-monitoring to inform insulin dosing. It has now met that goal in an initial study, but pivotal data will be needed to convince FDA.
You may also be interested in...
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.
On the latest Medtech Insight podcast, David Filmore and Ferdous Al-Faruque discuss the unexpected news that Scott Gottlieb is leaving US FDA next month. What has been his legacy for medtech, and who will replace him?
The commissioner says he will step down next month, leaving a legacy of active policy development, but also a lot of initiatives and pilot projects that are in the middle of being implemented.