11-03-2024
PulseCath Achieves MDR CE Certification for iVAC 2L
We proudly announce the successful achievement of the transition from Medical Device Directive (MDD) CE marking to Medical Device Regulation (EU) 2017/745 (MDR) for our groundbreaking product, iVAC 2L.
The MDR CE certification signifies PulseCath’s commitment to the highest standards of quality and safety in medical devices. This achievement marks a significant milestone for PulseCath and underscores our commitment to delivering innovative solutions that meet the highest regulatory standards. iVAC 2L represents a leap forward in complex High-Risk PCI’s, and we are eager to make this transformative device available to healthcare providers and patients worldwide.
Please follow this link for the official press release.