ETView lands FDA clearance for endobronchial blocker
Israeli company ETView Medical (TLV:TLV) won FDA 510(k) clearance for its Viva EB endobronchial blocker, a balloon-tipped imaging-guided single-use catheter, which it initially applied for in February. ETView plans to enter the U.S. market immediately, and additional pre-market regulatory filings in Europe and Asia are anticipated during 2012.
Melicor wins FDA OK for surgery cleaning system
Colorado startup Melicor Medical won FDA approval for its LLICS system, which cleans laparoscopic devices during surgery. The disposable device is make of plastic and will cost less than $100 once it hits the market.
Neurotech S.A. wins CE Mark for epilepsy treatment
Belgium-based Neurotech S.A. touted CE Mark approval in the European Union for its ADNS-300 vagus nerve stimulation system for treatment of refractory epilepsy.