FDA Warning Letter Cites Quality Control Issues At Abbott Diabetes Care
This article was originally published in The Gray Sheet
Executive Summary
Abbott's Diabetes Care division did not follow internal protocols for quality control testing of its FreeStyle blood glucose monitoring systems and FreeStyle Navigator continuousglucose monitoring systems, FDA alleged in a July 2 warning letter to the firm
You may also be interested in...
Abbott’s Recommitment To Core Diagnostics Is Rewarded By Strong Returns
Abbott has a newfound loyalty to its long-struggling core diagnostics business, which the company was at the brink of unloading just last year, and the division has responded with a dramatic turnaround
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.
Finance Watch: Canaan, Regeneron Reveal New Funds For Start-Ups
Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to $1bn-plus. Also, incubators plan to grow over the next decade and in recent financings Avenzo raised $150m and Nvelop launched with $100m.