Mar. 2 at 1:29 AM
$IPIX Based on BeaMed’s own statements
- They expected clearance “potentially in 2024.”
- It is now 2026, and no clearance has been published.
Typical 510(k) review duration
- Standard review: 90 days
- With additional information requests: 6–12 months
- Complex neurosurgical devices often trend toward the longer end.
Assumptions
- High probability that a submission was made (based on investor communications).
Because the FDA database shows no decision, the most likely scenario is:
- The 510(k) is still under review,
- Or the submission was delayed,
- Or the device is being routed through a different regulatory pathway (e.g., De Novo).
I wonder if there is someone with appropriate access to look into the FDA database to see the status of the application.
