kronos electrocautery device
Single Pass
FDA Clearance Information
Frequently Asked Questions
What problem is SinglePass Kronos trying to solve?
Post-biopsy bleeding risk and the downstream need for prolonged observation, repeat imaging, or intervention; it’s intended to provide tract hemostasis via electrocautery.
What tissues/organs are in the FDA indication?
Liver, kidney, and lung soft tissue (per FDA indications for use).
Is this a vascular closure device?
No—this is a biopsy tract electrocautery/hemostasis tool (tract management after coaxial biopsy).
What’s the best available clinical evidence right now?
Two small case-series publications (kidney and liver biopsies), each n=5, reporting no post-procedure bleeding on imaging and no complications through 30 days.
Does it definitively reduce admissions/length of stay?
Not definitively from controlled data. The concept and post-market evaluation target observation time and workflow, but published evidence is not yet comparative
What are the major unanswered questions?
Comparative effectiveness vs standard tract management (gelfoam/plugging/manual pressure), real-world complication rates at scale, and performance in higher-risk anticoagulated/coagulopathic populations.