FDA has labeled a DexCom alert about alarm activation failures with its G4 Platinum and G5 Mobile continuous glucose monitoring systems as a class I recall.
DexCom Inc.'s February alert about alarm problems with its G4 Platinum and G5 Mobile continuous glucose monitors for diabetics has been tagged as a class I recall, FDA said
April 11. The recall involves all models and all lots of the CGMs – a total of 263,540 units worldwide.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
