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Medical Device Approvals

New Products In Brief

This article was originally published in The Gray Sheet

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Executive Summary

Recent market launches include iWalk’s BiOM AK bionic ankle, Mevion’s S250 proton beam radiation therapy system and Smith & Nephew’s Truclear 5.0 for polyps removal.

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News In Brief

Spectrum buys majority stake in Shaser Bioscience. Sorin snaps up Neurotech. Nihon Kohden acquires Defibtech. More news briefs.

Argo Preps 510(k) Application For ReWalk Exoskeleton For Home Use

The firm launched the CE-marked, first-of-its-kind device for personal home use in Europe in early September at the International Spinal Cord Society meeting in London.

Financings In Brief

InspireMD plans stock offering to raise up to $46 million for stent system. Torax gets $30 mil. for GERD treatment. BioFire Diagnostics raises $25 mil. for FilmArray platform. More financings.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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