Cyber security vulnerabilities in medical device networks – and why AI might not be a silver bullet

By Anjuman Rahman

31 Jan 19

Cyber security threats in medical device networks are evolving to become more sophisticated - risking patients' lives -…

Patient Care DevicesApprovalsPatient Care Monitoring

FDA seeks additional information from Helius Medical for PoNS Device

By NS Medical Staff Writer

28 Jan 19

The US Food and Drug Administration (FDA) is seeking additional information (AI) related to Helius Medical Technologies request…

Regulatory PolicyRegulation

How a no-deal Brexit could impact the medical devices sector

By Anjuman Rahman

23 Jan 19

The British Medical Association has warned the UK medical devices sector it will become vulnerable should Britain leave…

Drug DeliveryRegulationRegulatory Policy

Boston Biomedical joins Factory-CRO’s worldwide group

By NS Medical Staff Writer

11 Jan 19

Global contract research organization (CRO) Factory-CRO Group has merged with Boston Biomedical Associates (BBA) to form a global…

RegulationRegulatory Policy

Axonics submits interim data to FDA for sacral neuromodulation system

By NS Medical Staff Writer

03 Jan 19

Medical technology company Axonics Modulation Technologies has submitted interim clinical data to the US Food and Drug Administration…

RegulationRegulatory Policy

Titan Medical extends global patent portfolio for single-port robotic surgery

By NS Medical Staff Writer

19 Dec 18

Titan Medical has announced seven new patent grants and notices of allowance related to its single-port robotic surgery…

RegulationRegulatory Policy

Cerus files for CE Mark registration for INTERCEPT RBC system

By NS Medical Staff Writer

19 Dec 18

Cerus, a biomedical products company focused in the field of blood transfusion safety, has filed for CE Mark…

RegulationRegulatory Policy

BioCardia submits application in US for AVANCE Steerable Introducer

By NS Medical Staff Writer

12 Dec 18

BioCardia has submitted its application for 510(k) with US Food and Drug Administration (FDA), for its new product,…

RegulationRegulatory Policy

Olympus Medical to pay $85m to settle charges with US DOJ

By rdharma

12 Dec 18

Olympus Medical Systems has agreed to pay $85m to the US Department of Justice (DOJ) to resolve charges…

RegulationRegulatory Policy

Invivoscribe submits LeukoStrat CDx FLT3 assay in US, Japan as companion diagnostic for quizartinib

By NS Medical Staff Writer

28 Nov 18

Invivoscribe has submitted LeukoStrat CDx FLT3 mutation assay to both the US FDA and the Japan Pharmaceuticals and…

RegulationRegulatory Policy