FSS touts CE Mark win for new self-expanding stent sizes
Flexible Stenting Solutions won CE Mark approval in the European Union for new sizes of its FlexStent iliac self-expanding stent system with indication for treatment of symptomatic atherosclerosis in the common or iliac arteries.
Synergetics lands FDA win for VersaVIT system
Synergetics (NSDQ:SURG) received FDA 510(k) clearance for its VersaVIT vitrectomy system, which the company calls a "game changer" for retinal surgery.
InTouch Health wins 510(k) for expanded use of its remote presence devices
InTouch Health landed 510(k) clearance for expanded use of its telemedicine devices to allow pre-, peri-operative and post-surgical monitoring for cardiovascular, neurological, pre-natal, psychological and critical care assessments and examinations.
SHL Telemedicine receives FDA approval for its mobile ECG
SHL Telemedicine won FDA approval for its Smartheart mobile electroencephalogram for smartphones, include iOS, Android and Blackberry platforms.
Surefire Medical announces FDA win for high-flow microcatheter
Colorado-based Surefire Medical touted an FDA win for its next-generation Surefire High-Flow Microcatheters, designed to delivery therapy with higher infusion efficiency than conventional microcatheters.