Mbot likely fda approval date

Microbot Medical's LIBERTY Endovascular Robotic System is currently under FDA review, with an anticipated FDA marketing clearance in the third quarter of 2025. Here's a detailed analysis: 1. **Current FDA Status**: The FDA review for the LIBERTY Endovascular Robotic System is ongoing, with the company having submitted a 510(k) premarket notification in December 2024. 2. **Anticipated Approval Date**: Microbot Medical has indicated that they anticipate FDA marketing clearance during the second quarter of 2025. This timeline remains consistent with the original review window, as confirmed by the company's CEO, Harel Gadot. 3. **Key Milestones**: The company has recently appointed additional commercial leadership, including Michael Lytle as head of Sales Operations & Analytics, and Christina Bailey as VP of Sales. These moves are part of strengthening the commercial infrastructure in preparation for the anticipated launch of the LIBERTY System in Q3 2025. 4. **FDA Review Process**: The FDA's 510(k) decision for the LIBERTY System is now expected in Q3 2025, which aligns with the planned launch timeline. The company has been engaging productively with the FDA and has completed the necessary clinical trials and testing required for FDA clearance. In conclusion, Microbot Medical's LIBERTY Endovascular Robotic System is likely to receive FDA approval in the third quarter of 2025, based on the company's submission in December 2024 and the anticipated review process.