The U.S. has granted final approval to Microvention Inc., a subsidiary of Terumo Corp. based in Aliso Viejo, Calif., for its Flow Redirection Endoluminal Device (FRED) for the treatment of brain aneurysms. The flow diverter – Microvention’s third PMA approval in less than two years – is the first in the U.S. to utilize a self-expanding, braided nitinol mesh to aid in rerouting blood flow away from the weakened area and promote occlusion.

Neovasc Inc., of Richmond, British Columbia, has submitted a premarket approval application to the U.S. FDA for its Neovasc Reducer. The minimally invasive stent, which was granted breakthrough status in October 2018, is used to treat refractory angina.

Seven years after an advisory hearing on the subject, the FDA has determined that cranial electrotherapy stimulation (CES) devices will be slotted as class III devices when used for depression. The decision comes despite a number of irregularities that took place at the February 2012 advisory hearing.