Diagnostics & Imaging
Evident Vascular Guidance System
FDA 510(k)-cleared intravascular ultrasound platform with plug-and-play peripheral catheters and voice control.
The Signal
Cleared under K261648 with a decision dated October 28, 2026, announced November 4. Flushless plug-and-play peripheral catheters, voice control and real-time processing on NVIDIA accelerated computing. Not yet available for sale; clearance is not approval.
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