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…

RegulationRegulatory Policy

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…

RegulationApprovals

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…

RegulationApprovals

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…

RegulationApprovals

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…

RegulationApprovals

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…

RegulationApprovals

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…

RegulationApprovals

CathWorks seeks FDA approval for FFRangio System

By NS Medical Staff Writer

23 Aug 18

Medical technology company CathWorks is seeking approval from the US Food & Drug Administration (FDA) for its FFRangio…

RegulationApprovals

Evolus secures marketing approval for DWP-450 in Canada

By NS Medical Staff Writer

20 Aug 18

Medical aesthetics company Evolus has secured approval from Health Canada for DWP-450 (prabotulinumtoxinA) to temporarily improve the appearance…

RegulationApprovals