Intuitive submits premarket notification to FDA for robotic-assisted lung biopsies platform

By NS Medical Staff Writer

07 Sep 18

Intuitive Surgical has submitted a premarket notification to the US Food and Drug Administration (FDA) for its robotic-assisted,…

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Health Canada approves Cutera’s truSculpt iD non-surgical body contouring system

By NS Medical Staff Writer

07 Sep 18

Laser and other energy-based aesthetic systems provider Cutera has secured approval from Health Canada for its truSculpt iD…

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ResMed lodges patent infringement petition against Fisher & Paykel

By NS Medical Staff Writer

03 Sep 18

ResMed, a tech-driven medical device firm, has lodged a patent infringement petition against New Zealand-based medical device manufacturer…

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Embolx gets CE mark for Sniper balloon occlusion microcatheters

By NS Medical Staff Writer

03 Sep 18

Medical device firm Embolx has secured CE mark approval for its next-generation Sniper balloon occlusion microcatheters for pressure-directed…

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Insys’ epinephrine nasal spray gets fast track status to treat anaphylaxis

By NS Medical Staff Writer

31 Aug 18

Insys Therapeutics has secured a fast track designation from the US Food and Drug Administration (FDA) for its…

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Parker secures CE mark for UltraDrape barrier & securement dressing

By NS Medical Staff Writer

30 Aug 18

Parker Laboratories has secured CE mark for UltraDrape, a combination sterile barrier and securement dressing for ultrasound-guided peripheral…

RegulationApprovals

ivWatch Model 400 medical device secures CE Mark

By NS Medical Staff Writer

30 Aug 18

ivWatch, a medical device manufacturer and biosensor technology firm, has secured CE mark approval for its ivWatch Model…

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FDA approves Ceterix Orthopaedics’ new suture cartridge

By NS Medical Staff Writer

29 Aug 18

Ceterix Orthopaedics has secured 510 (k) clearance from the US Food and Drug Administration (FDA) for new suture…

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FDA grants breakthrough device status for Dthera’s Alzheimer’s focused product

By NS Medical Staff Writer

27 Aug 18

Dthera Sciences has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its development…

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Gore molding & occlusion balloon catheter secures approval in US, Japan, and Europe

By NS Medical Staff Writer

24 Aug 18

W. L. Gore & Associates, a US-based multinational manufacturing firm specializing in products derived from fluoropolymers, has secured…

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