The CE marking – Conformite Europeenne – certifies that the product meets European Union (EU) requirements for marketing in Europe
BrainTale, a French innovative company specialized in the development of software as a medical device for the quantitative measurement of the brain microstructure and the prognostication of the recovery outcome announces today its ISO 13485 :2016 certification and the CE marking of its first product, brainQuant.
The company received ISO 13485:2016 certification, an international standard governing the requirements of a quality management system for medical devices and related company services. The CE marking – Conformite Europeenne – certifies that the product meets European Union (EU) requirements for marketing in Europe.
BrainTale develops and commercializes accessible, effective and clinically-validated measurement and prognosis tools for brain injured patients. The solutions are based on standardized magnetic resonance imaging (MRI) measurements with systematic quality checks, artificial intelligence algorithms derived from prospective clinical trials with large patient cohorts over several years led by AP-HP (Assistance Publique – Hôpitaux de Paris), prognosis performances addressing clinical needs and delivered in clear, understandable reports for physicians and patient’s families. The solutions deployed by BrainTale were developed based on the work of the clinical teams of AP-HP and resulted in the filing of patent and proprietary-software applications.
BrainQuant is a SaaS solution providing regional quantitative measurement of the white matter microstructure from diffusion MRI after brain injuries, such as traumatic brain injury, cardiac arrest, stroke or neurological diseases. Its unique value proposition is based on its ability to provide standardized quantification of white matter injuries within the brain that is impossible with standard medical imaging, hence providing healthcare professionals with certified, quantitative and qualitative analysis of patients’ brain. BrainQuant will be available within certified hospital centers, after professionals training and MRI calibration.
“This news is a major achievement allowing healthcare professionals to use our first product in compliance with EU requirements. We are very excited about this new era of providing professionals with CE-cleared, clinically-demonstrated and efficient digital tools to provide relevant information to allow appropriate patient’s journey”, comments Vincent Perlbarg, the company’s president.
The company’s second product in development is brainScore, a SaaS solution combining brainQuant and artificial intelligence algorithms for predicting coma emergence for patients in intensive care units after severe traumatic brain injuries or cardiac arrest.
Source: Company Press Release