Medical devices
The IHU ICAN has been able to forge privileged links with many medical device companies and has a SNITEM representative on its Board of Directors.
The IHU ICAN aims to promote translational research in the field of cardiometabolic diseases and nutrition, and has participated in the development of several innovative medical devices.
The IHU ICAN strives to support manufacturers of innovative medical devices to meet the new preclinical and clinical requirements introduced by European regulations 2017/745 for medical devices and 2017/746 for in vitro diagnostic medical devices.
ICAN has many resources to offer services to manufacturers of medical devices:
- Advice and targeted expertise on preclinical and clinical strategy in the field of cardiometabolism and nutrition pathologies ( NASH , heart failure , diabetes and chronic wounds , rare diseases , etc.).
- Identification of patient needs and participation in clinical suitability assessments.
- Advice on the identification of patient needs, the definition of the expected performance and the target population of the medical device.
- Design, realization and analysis of in vitro and ex vivo preclinical studies ( iPS cells , human liver tissues , metabolomics and lipidomics analysis ).
- Scientific and medical support for the design of the clinical evaluation or performance evaluation plan.
- Scientific and medical support for the drafting of clinical study protocols.
As part of the implementation of a clinical evaluation plan, the IHU ICAN has a clinical investigation platform specializing in the recruitment of patients suffering from cardiometabolic and nutritional pathologies, and relying on :
- A location in the heart of the Pitié-Salpêtrière hospital
- A Biological Resource Center in the immediate vicinity (identification, technology, conservation) – ISO 9001 and NF S 96-900 certified
- A dedicated team (Clinical research doctor, IDE, TEC experts)
- Highly specialized analysis platforms ( lipidomics , metabolomics , cytology ).