Medtronic wins FDA clearance for Affera Prism-2 cardiac mapping software
MDT•Medtronic received FDA clearance and CE Mark for its Affera Prism-2 Mapping Software for cardiac ablation procedures; CE Mark was also granted for the PulseSelect ProxBox Adapter with Proximity Indicator software.
1. Regulatory clearances
Medtronic received FDA clearance and CE Mark for its Affera Prism-2 Mapping Software for use in cardiac ablation procedures. The PulseSelect ProxBox Adapter with Proximity Indicator software also received CE Mark, adding real-time tissue proximity feedback.
