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.
PCOx is Covidien’s next-generation mesh for repair of ventral hernias, which are bulges or tears in the abdominal wall that typically occur in muscles weakened from previous surgical incisions.
This new iteration of the Parietex product boasts a more resistant barrier and a stronger and more visible textile design, according to the release.
Covidien’s study of the Parietex ProGrip for the repair of inguinal hernias closed last month.
Animas Corp., a subsidiary of Johnson & Johnson (NYSE:JNJ), announced that it’s Animas Vibe insulin pump enabled with continuous glucose monitoring technology developed by DexCom Inc. (NSDQ:DXCM) won CE Mark approval in the European Union. This is good news for Animas, which recalled 400,000 insulin cartridges in March due to a risk of leakage.
ThermoGenesis Corp. (NSDQ:KOOL) won FDA clearance for its Res-Q 60 system for preparation of cell concentrates. The Rancho Cordova, Calif.-based company won clearance for Res-Q 60 in India in April.