Medtronic secures licence from Health Canada MiniMed 670G insulin pump system

By NS Medical Staff Writer

12 Oct 18

Medtronic of Canada, a subsidiary of Medtronic has secured a licence from Health Canada for the MiniMed 670G…

RegulationApprovals

FDA declines to approve TearLab’s dry-eye test

By NS Medical Staff Writer

11 Oct 18

TearLab's Discovery MMP-9 Test has failed to meet criteria for substantial equivalence based upon data and information submitted…

RegulationRegulatory Policy

K2M secures FDA nod including surgical guidance that improves MESA platform

By NS Medical Staff Writer

11 Oct 18

K2M Group Holdings announced at the Scoliosis Research Society 53rd Annual Meeting & Course, in Bologna, Italy, a…

RegulationApprovals

FDA grants expanded indication for Vapotherm’s Precision Flow Hi-VNI system

By NS Medical Staff Writer

10 Oct 18

The US Food and Drug Administration (FDA) has granted an expanded indication for Vapotherm's Precision Flow Hi-VNI system…

RegulationApprovals

MedISAO signs MOU with FDA’s CDRH and NH-ISAC

By NS Medical Staff Writer

05 Oct 18

MedISAO, a provider of cybersecurity information, education and tools for the medical device industry, has signed a memorandum…

RegulationRegulatory Policy

MEMS devices provider Sensera achieves ISO 13485 quality certification

By NS Medical Staff Writer

05 Oct 18

Sensera said that it is now certified to the ISO 13485:2016 quality standard. ISO 13485:2016 specifies requirements for…

RegulationCertifications

French HAS recommends use of Axumin in PET imaging of suspected recurrent prostate cancer

By NS Medical Staff Writer

04 Oct 18

The Transparency Committee of the French Haute Autorité de Santé (HAS) has given positive recommendation to Blue Earth…

RegulationRegulatory Policy

ivWatch extends global patent portfolio, brings total owned patents to seven

By NS Medical Staff Writer

03 Oct 18

ivWatch has received two patents granted by the European and Japanese Patent Offices expanding their intellectual property (IP)…

Diagnostic DevicesRegulationRegulatory Policy

Qiagen secures FDA approval to extend EGFR test use in lung cancer

By NS Medical Staff Writer

01 Oct 18

Qiagen has secured the US Food and Drug Administration’s (FDA) approval, which enbales use of therascreen EGFR RGQ…

RegulationApprovals

Invivoscribe secures approval for LeukoStrat CDx FLT3 mutation assay in Japan

By NS Medical Staff Writer

28 Sep 18

Invivoscribe has secured approval in Japan for LeukoStrat CDx FLT3 Mutation Assay companion diagnostic to assess acute myeloid…

RegulationApprovals