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…

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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…

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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…

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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…

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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…

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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,…

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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…

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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…

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FDA plans to overhaul 510(k) approval process for medical devices

By NS Medical Staff Writer

28 Nov 18

The US Food and Drug Administration (FDA) is planning to overhaul the framework for evaluating the safety and…

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FDA issues warning letter to Ocular Therapeutix over ReSure sealant

By NS Medical Staff Writer

22 Oct 18

Ocular Therapeutix has received a warning letter from the US Food and Drug Administration (FDA) related to ReSure…

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