AI devices with FDA product code HAW — Neurological Stereotaxic Instrument
Product code HAW (“Neurological Stereotaxic Instrument” in openFDA) covers 8 devices on the FDA AI-enabled list, from 6 companies. Most are reviewed by the Neurology panel (8). The most recent decision was Stealth AXiS Cranial clinical application on March 26, 2026.
8AI devices
5Companies
2019First decision
2026-03-26Latest decision
Trend: devices per year
20192023202420252026
Top companies
All 8 devices, newest first
- Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · Neurology
- ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc. · Neurology
- FLASH EVD System (10-0002)7D Surgical ULC · Neurology
- ClearPoint System (Software Version 2.2)ClearPoint Neuro Inc. · Neurology
- Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software CranialBrainlab AG · Neurology
- Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRIBrainlab AG · Neurology
- Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning CranialBrainlab AG · Neurology
- 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical Inc. · Neurology