Cardiawave SA
Cardiawave is dedicated to improving patient care through innovative non-invasive ultrasound therapies for cardiovascular diseases, particularly calcific aortic stenosis. Their mission is to develop breakthrough medical devices that offer effective, safe, and less invasive treatment options, reducing healthcare costs and enhancing quality of life for patients.
Industries
Nr. of Employees
small (1-50)
Cardiawave SA
Paris, Ile-de-France, France, Europe
Products
Investigational non‑invasive focused ultrasound therapy device
A real‑time image‑guided medical device that delivers focused pulsed ultrasound (mechanical, non‑thermal) to soften calcified aortic valve leaflets and improve valve mobility; intended for clinical investigation.
Investigational non‑invasive focused ultrasound therapy device
A real‑time image‑guided medical device that delivers focused pulsed ultrasound (mechanical, non‑thermal) to soften calcified aortic valve leaflets and improve valve mobility; intended for clinical investigation.
Services
Clinical research and trial execution
Design and conduct of first‑in‑human and pivotal multi‑center clinical investigations, including site selection, enrollment, monitoring and study reporting.
Clinical application support and training
On‑site clinical engineering support, operator training, procedural assistance and feedback to R&D to optimize device usability and clinical workflows.
Medical device software development and integration
Design and implementation of control software, real‑time GUIs, integration of third‑party control components, and maintenance via CI/CD pipelines.
Regulatory and quality management support
Implementation of a certified QMS, support for clinical trial authorizations, and participation in regulatory submission activities for market access.
Clinical research and trial execution
Design and conduct of first‑in‑human and pivotal multi‑center clinical investigations, including site selection, enrollment, monitoring and study reporting.
Clinical application support and training
On‑site clinical engineering support, operator training, procedural assistance and feedback to R&D to optimize device usability and clinical workflows.
Medical device software development and integration
Design and implementation of control software, real‑time GUIs, integration of third‑party control components, and maintenance via CI/CD pipelines.
Regulatory and quality management support
Implementation of a certified QMS, support for clinical trial authorizations, and participation in regulatory submission activities for market access.
Expertise Areas
- Non‑invasive cardiovascular therapy development
- Focused ultrasound therapy R&D
- Clinical trial design and multi‑center execution
- Medical device software and image‑guided systems
Key Technologies
- Focused ultrasound therapy
- Pulsed cavitational ultrasound / shockwave generation
- Real‑time ultrasound image guidance
- Robotic/beam‑steering targeting of moving organs