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BrainTale gets ISO:13485:2016 certified, and CE marking for BrainQuant

Date: April 03, 2020 Sunil Jha Sunil Jha
BrainTale gets ISO:13485:2016 certified, and CE marking for BrainQuant 
    
	
  • The solutions are said to be based on artificial intelligence algorithms stemming from prospective clinical trials having huge patient cohorts.
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  • The solutions used by the company were developed keeping the work of the clinical teams of AP-HP in mind.
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France-based innovative company BrainTale has reportedly acquired the CE marking of its first product BrainQuant and ISO:13485:2016 certification. BrainTale apparently commercializes and develops effective, accessible and clinically-validated prognosis and measurement tools for brain injured patients.



The solutions are said to be based on artificial intelligence algorithms stemming from prospective clinical trials having huge patient cohorts and standardized magnetic resonance imaging (MRI) measurements with systematic quality checks. It is worth noting that these solutions are spearheaded by Assistance Publique – Hopitaux de Paris (AP-HP), prognosis performing addressing clinical requirement.



Apparently, the solutions used by the company were developed keeping the work of the clinical teams of AP-HP in mind, thereby leading to the filing of proprietary-software applications and patent.



It is reported that BrainQuant is a SaaS solution offering regional quantitative measurement of the white matter microstructure stemming from diffusion MRI post brain injuries, including cardiac arrest, traumatic brain injury, and stroke or neurological diseases.



President of BrainTale Vincent Perlbarg was exalted and said that the announcement would leverage healthcare professionals to use BrainQuant in line with EU requirements. He was quoted to be sanguine about the new epoch of professionals with clinically-exhibited and CE-cleared and efficient digital equipment to offer viable information to enable ideal patient’s journey.



For the uninitiated, BrainTale got ISO 13485:2016 certification—an international standard governing the need of a quality management system for medical devices, and other related services. Further, Conformite Europeene (CE) certifies that the product keeps up with the European Union (EU) needs for marketing in Europe.



BrainQuant is slated to be available within hospital centers which are certified following MRI calibration and professional training.



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https://www.businesswire.com/news/home/20200402005028/en/BrainTale-Announces-CE-Marking-Product-Brain-Quantitative

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Sunil Jha

Sunil Jha has been a part of the content industry for close to two years. Having previously worked as a voice over artist and sportswriter, he now focuses on writing articles for newsorigins.com, across a slew of topics, ranging from technology to trade and finance. With a business-oriented educational background, Sunil brings forth the expertise of deep-dive research and a strategic approach in his write ups.