N.B.Medical provides a regulation‑integrated computational modeling and simulation platform combined with AI‑driven digital‑twin technology for neurovascular device development. The system automates design validation, generates compliant documentation, and predicts device performance through an in‑house finite‑element solver, accelerating prototyping and regulatory submission for manufacturers and CROs.
Funding
Funding not disclosed
Founders
Product
Problem
Neurovascular device development is constrained by lengthy design cycles, high prototyping costs, and complex regulatory approval processes that require extensive testing and documentation. These challenges limit the speed at which innovative stents and coatings can reach patients with cerebrovascular diseases.
Solution
N.B.Medical combines physical device engineering with a proprietary, regulation‑integrated Computational Modeling & Simulation (CMS) platform and AI‑driven digital‑twin technology. The CMS embeds regulatory requirements into every design iteration, while AI automatically generates compliant documentation linked to real‑world testing data. An in‑house finite‑element (FE) solver enables virtual deployment and performance prediction of neurovascular devices before physical prototyping. This integrated workflow reduces development time, improves design precision, and streamlines regulatory submissions, delivering next‑generation neurovascular products to market more efficiently.
Target Audience
Primary customers are neurovascular device manufacturers and OEMs seeking accelerated development cycles, as well as clinical research organizations that require high‑fidelity virtual testing and regulatory‑ready documentation.
Features
- Regulation‑integrated CMS that enforces global standards (e.g., ISO 13485, FDA 21 CFR 820) throughout the design‑to‑manufacturing pipeline
- AI‑enabled documentation engine that auto‑populates technical files, risk analyses, and validation reports from simulation outputs
- Digital‑twin framework that synchronizes virtual device models with physical prototypes for continuous validation
- In‑house finite‑element analysis (FEA) solver for virtual stent deployment, stress‑strain mapping, and fatigue prediction
- Nano‑coating platform delivering antithrombotic and cell‑adhesive surface treatments for neurovascular implants
- Hybrid‑structure stent architecture offering high flexibility, low foreshortening, resheathability, and superior structural integrity
- Automated compliance verification workflow that flags design deviations against regulatory checkpoints in real time
- Secure cloud‑based data repository for simulation results, design revisions, and audit trails, supporting traceability and collaboration