CADence Coronary Blockage Detection Device Success
Solutions Engineering is proud to congratulate their long time client, AUM Cardiovascular, on receiving European regulatory approval earlier this year and successfully raising $5 million in equity financing for their CADence coronary blockage detection device.
Solutions Engineering was a major player in the development of the CADence device. Working alongside the award winning industrial design team at MNML, Solutions Engineering delivered the complete package of electronics and software design. This package encompassed everything from the very first prototype to the build of clinical study devices.
Not only was Solutions Engineering a large part of the development of the device, but SE was instrumental in the certification process. Their cost effective “Design Controls” process enabled the device and its documentation to pass their ISO13485 audit with honors. The auditor referred to the software methods and documentation as “some of the best I’ve ever seen.”
Solutions Engineering wishes AUM Cardiovascular continued successes as CADence rolls out to the U.S. market following its upcoming U.S. regulatory approval.