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MRI Imaging data acquisition (clinical investigation)

TEF-Health Service
Physical
Pricing/Discount Options: Call #2
Unique Identifier: 1b337507-5539-45c1-b630-8503c5773e3a

Service Description

CEA contributes its Biomedical & Clinical research center called Clinatec, specialized in neurotechnologies. It involves a multi-disciplinary team with neuroscientists, Imaging experts, Hardware and software engineers, Clinical research assistants, neurosurgeons and nurses, project managers, … It addresses neurotechnology development from early-stage concept to pilot clinical trial (TRL1 to TRL6).

The NeuroImaging platform includes the following: - MRI 1.5T (Siemens Espree) - MEG/EEG (Elekta Neuromag) : 204 gradiometers, 102 magnetometers, 128 EEG channels. - MRI/MEG-compatible EEG amplifier (Brain Products) : 64 channels. - Audio, visual and sensitive stimulation equipment - Dedicated HPC workstation for real-time signal processing

The service offers to conduct clinical studies with MEG/EEG/MRI Imaging to generate new brain-related data: - Data acquisition & analysis +/- technical expertise. - Clinical and regulatory support to set up and submit the clinical study within French regulatory framework. - Example: provide new clinical data to assess/validate the performance/robustness of an AI system in a specific intended use

Keywords: MEG MRI Neuroimaging Imaging data acquisition
Service categories: Testing Imaging (MRI, MEG, PET, CT, Microscopy, etc.)
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Organisation Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)
Provider Country France
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Billing: per exam
Full Price Negotiated
Reduced Price Negotiated
Pricing Detail

from 250 EUR

Reduced: from 175 EUR

Operational Details

Service Inputs CEA can help with: • Project design • Clinical study set up • MRI acquisition (& MEG/EEG) • Data analysis & evaluation • Hardware/software evaluation • Regulatory and clinical support The service is delivered in tight collaboration with the Grenoble-Alpes University Hospital, thus ensuring the appropriate medical expertise availability
Service Outputs Small-scale pilot demonstrating feasibility and preliminary safety, clinical operability, and efficacy with healthy users. In the context of the development of an instrument or an algorithm CEA will propose a regulatory exist-ing framework for small cohorts (no more than 10 participants). • MRI/MEG/EEG acquisition • Data analysis & evaluation • Hardware/software evaluation • Regulatory and clinical support • Hardware/software evaluation • Reporting
Certification Support Medical Device Regulation ; ISO 14155:2020
  • ISO 14155
  • MDR
Service Standards
  • Clinical research center: GCP
  • ISO 9001

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