Case Study: Medviso achieves FDA 510(k) approval and CE marking with MathWorks' MATLAB

Medviso Receives FDA 510(k) Approval and CE Marking for Cardiovascular Analysis Software

Medviso, a medical imaging company, needed to turn research-grade cardiac image analysis algorithms into a certified clinical product and secure regulatory clearance. Using MATLAB from MathWorks (with Image Processing Toolbox and MATLAB Compiler), the team had to create a user interface, package a standalone application, and meet strict FDA 510(k) and CE/ISO 13485 documentation and regression-testing requirements.

Medviso used MathWorks’ MATLAB to develop, test, document, and package its Segment CMR software—writing automated regression tests and code-based documentation and compiling a standalone app with MATLAB Compiler. The result: FDA 510(k) approval and CE marking, clinical use in Europe and the U.S., adoption by over 300 research groups, a threefold increase in development speed, FDA submission effort cut in half (with documentation and a compiled build produced in about 20 minutes), and ~75% code reuse for the new Segment CT product.

Medviso

Helen Fransson

Chief Executive Officer