Cardiology
Saranas Early Bird Bleed Monitoring System
Saranas Inc.
FDA-cleared AI medical device
An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.
FDA Submission Metadata
- Submission number
- K230273
- Decision date
- May 2023
- FDA panel
- Cardiovascular
- Product code
- QFJ
- Clinical task (npj)
- triage
- Data modality (npj)
- Signals
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.