What is the percentage of likelihood MBOT is FDA approved?
7/25/2025 11:11am
The percentage of likelihood that Microbot Medical (MBOT) is FDA approved is estimated to be between 60% and 80%. Here's a breakdown of the factors contributing to this estimation:
1. **Current FDA Review Status**: MBOT has submitted the 510(k) premarket notification for the LIBERTY System in December 2024, and the FDA review is in its final stages.
2. **Anticipated FDA Review Timeline**: The FDA's 510(k) decision for the LIBERTY System is expected in Q3 2025, with an anticipated decision during the month of July or August.
3. **Company Progress**: MBOT has been actively preparing for the anticipated launch of the LIBERTY System, including expanding its commercial team and appointing key executives.
4. **Market Readiness**: The company has been building commercial infrastructure and engaging with strategic partners to facilitate distribution, indicating market readiness for the anticipated launch.
Considering these factors, the likelihood of FDA approval is significant, but it is not guaranteed. The 60% to 80% estimation takes into account the company's progress, the FDA review timeline, and the anticipated decision date.
Please note that these are estimates and the actual outcome may vary.