Brainsway wins CE Mark approval for chronic pain brain-stim implant
Israeli device maker Brainsway won CE Mark approval in the European Union for its Deep TMS neurostimulation device for treatment of chronic, or neuropathic, pain.
The new approval marks the 6th CE Mark application for the Deep TMS device, joining clinical depression, bi-polar disorder, schizophrenia (negative symptoms), Parkinson’s diseases and post-traumatic stress disorder.
Abbott touts FDA approval for protective gel for cataract surgery
Abbott (NYSE:ABT) won FDA approval for a new element in its family of Healon ophthalmic viscosurgical devices, intended for use as a surgical aid in cataract extraction and intraocular lens implantation.
The gel is injected into a patient’s eye to protect and coat it during surgery, reducing trauma to the inside layer of the cornea and surrounding tissues.
ETView Medical lands CE Mark for Viva-EB endobronchial blockers
ETView Medical (TLV:TLV) touted CE Mark approval for the Viva-EB suite of endobronchial blockers, expecting commercial launch to commence immediately. The devices won FDA 510(k) clearance last month.