AliveCor secures FDA breakthrough device status for bloodless Hyperkalemia test

By NS Medical Staff Writer

11 Sep 18

The US Food and Drug Administration (FDA) has designated AliveCor’s KardiaK software platform, a bloodless Hyperkalemia test, as…

RegulationApprovals

IRIDEX gets FDA clearance for updated TruFocus LIO Premiere laser accessory

By NS Medical Staff Writer

10 Sep 18

IRIDEX has introduced its updated TruFocus LIO Premiere laser accessory, following US Food and Drug Administration (FDA) 510(k)…

RegulationApprovals

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…

RegulationApprovals

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