Focalist System
Ultrasound-guided needle-based procedures (e.g., Percutaneous Nephrolithotomy)
ApprovedActive
Key Facts
Indication
Ultrasound-guided needle-based procedures (e.g., Percutaneous Nephrolithotomy)
Phase
Approved
Status
Active
Company
About Mendaera
Mendaera is a private, pre-revenue medical device innovator based in Redwood City, California, focused on robotic-assisted procedural guidance. Its core product, the Focalist System, has received FDA clearance and represents a novel category of handheld robotics integrated with ultrasound imaging to improve needle placement accuracy. The company is backed by notable venture capital firms and is targeting a 2026 commercial launch, with initial clinical use demonstrated in advanced kidney stone surgery. Mendaera's mission is to democratize complex procedural skills, enabling safer and more consistent outcomes across healthcare settings.
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