Animas
Hacking: Another year, another insulin pump maker outed on stage
Diabetes: FDA puts highest-risk status on J&J’s Animas insulin pump recall
The FDA put its highest-risk category on Johnson & Johnson (NYSE:JNJ) subsidiary Animas Corp.’s insulin pump recall over concerns that the devices may cause patient harm or even death.
Diabetes: Certain J&J insulin pumps destined to fail over software issue
Johnson & Johnson (NYSE:JNJ) subsidiary Animas Corp. warned European regulators that certain of the company’s ambulatory insulin pumps contain a software flaw that will render the devices defunct on the stroke of midnight on December 31, 2015.
Diabetes: J&J’s artificial pancreas proves effective in 1st human clinical trials
A 1st-generation artificial pancreas by Johnson & Johnson (NYSE:JNJ) subsidiary Animas Corp. proved successful in managing inulin levels in patients with Type I diabetes, researchers unveiled over the weekend at the annual American Diabetes Assn. meeting in Philadelphia.
Covidien lands 510(k) clearance and CE Mark approval for its next-gen Parietex mesh | Regulatory Roundup
Covidien plc (NYSE:COV) announced a double-dose of regulatory wins for its Parietex Optimized Composite (PCOx) mesh, which received both 510(k) clearance from the U.S. Food & Drug Administration and CE Mark approval for the European Union.
Covidien launched PCOx during the recent European Hernia Society meeting in Ghent, Belgium, and the product will be commercially available in the U.S. and Europe starting in June.
Johnson & Johnson recalls nearly 400,000 Animas insulin cartridges
Johnson & Johnson (NYSE:JNJ) is recalling nearly 400,000 insulin cartridges made by its Animas subsidary because of the risk that they might leak insulin.
Animas sent out a letter to patients Feb. 24 detailing the recall, saying "some of the 2.0 mL insulin cartridges shipped between Nov. 30, 2010 and Jan. 4, 2011, can leak insulin, resulting in the delivery of less insulin than intended. In addition, if the cartridge has a leak, the pump may not alarm if there is an occlusion in the infusion set," according to the letter.