EndoSonics gets 510(k) clearance for MegaSonics catheter:
This article was originally published in Clinica
Executive Summary
The US FDA has cleared the MegaSonics coronary balloon and imaging catheter developed by EndoSonics. The device combines an electronic imaging catheter with a high pressure balloon on a nylon shaft, enabling it to be used for diagnosis and treatment. The additional SlyDx coating eliminates friction, according to the Rancho Cordova, California-based company, and makes rapid placement easier.