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FSS lands extended CE Mark for FlexStent | Regulatory Roundup

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MassDevice.com Regulatory Roundup

 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.
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 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.
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 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.
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 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.  
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 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.
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  • MedTrace Pharma moves forward on 15 O-water imaging tech
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