Abbott Laboratories received CE mark approval for two dual glucose and ketone sensing systems, bringing to the market sensors that could be transformational to the lives of people with diabetes at risk of diabetic ketoacidosis.

Insulet Corp. has initiated a voluntary medical device correction affecting insulin pump pods in its Omnipod product lines after discovering a manufacturing issue that could lead to the leaking of insulin and the under-delivery of doses in some patients. The company said that some pods from specific lots may have a small tear in the cannula.

Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency.