Focalist
JSON twin: https://www.healthaidb.com/software/focalist.json
Company Name
Product URL
Company URL
Categories
- clinical Care
- diagnostic Support
- surgical Care
- robotics
- imaging Software
- interventional Procedures
- pathology
- therapy Management
- pediatric Care
- chronic Care Management
- regulatory Compliance
- medical Device
- healthcare Technology
- medical Equipment
- Clinical
- Diagnostic
- Surgical
- Robotic-assisted
- Ultrasound-guided
- Interventional
- Minimally Invasive
- Urology
- Nephrology
- Biopsy
- Vascular Access
- Therapy Delivery
- Adult Care
- Fda-cleared
- Medical Robotics
- Surgical Instruments
- Patient Care
Summary
Focalist is a handheld robotic system developed by Mendaera to enhance precision in ultrasound-guided needle procedures, aiming to simplify and improve the accuracy of such interventions across various medical specialties.
Description
Focalist integrates handheld robotics with real-time ultrasound imaging and advanced software to support precise, repeatable instrument placement. It features touchscreen targeting, robotic needle positioning, and continuous needle depth-tracking, designed to assist clinicians in performing needle-based procedures with greater confidence and efficiency. Initially launched in urology for procedures like percutaneous nephrolithotomy (PCNL), Mendaera plans to expand Focalist's application to other specialties in 2026. The system has received FDA 510(k) clearance for use in pediatric and adult patients during diagnostic or therapeutic procedures involving standard interventional devices.
Api Available
no
Certifications
- FDA 510(k) clearance
Company Founding
2020
Company Offices
Compliance
- FDA 510(k) clearance
Customers
Data Residency
US
Data Standards
- DICOM
Deployment Model
- on_prem
Features
- Handheld robotic system
- Real-time ultrasound imaging
- Touchscreen targeting
- Robotic needle positioning
- Continuous needle depth-tracking
Id
SW2791
Integration Partners
Integrations
- Ultrasound imaging systems
Languages Supported
- English
- Spanish
- French
- German
- Italian
- Portuguese
- Dutch
- Russian
- Chinese
- Japanese
- Korean
- Arabic
- Hindi
- Bengali
- Punjabi
- Javanese
- Turkish
- Vietnamese
- Telugu
- Marathi
Last Updated
2025-10-11
License
commercial
Market Segment
- enterprise
- smb
- consumer
Optional Modules
- Advanced software for precise instrument placement
Os Platforms
- Windows
- Linux
Pricing Details
contact vendor
Pricing Model
subscription
Privacy Features
- Data anonymization
- Data minimization
Product Code
SW2791
Product Name
Focalist
Ratings
Regions Available
- United States
- Canada
- Europe
- Asia
- Australia
- South America
- Africa
- Middle East
- North America
- Latin America
- Caribbean
- Oceania
- Southeast Asia
- East Asia
- South Asia
- Central America
- Sub-Saharan Africa
- North Africa
- Central Asia
- Western Europe
Related Urls
Release Year
2025
Security Features
- Data encryption
- Role-based access control
- Audit logs
Specialties
- Urology
- Nephrology
- Interventional Radiology
- Surgery
- Pediatrics
- Adult Medicine
- Biopsy Procedures
- Vascular Access
- Therapy Delivery
- Minimally Invasive Surgery
- Robotic Surgery
- Ultrasound-guided Procedures
- Diagnostic Procedures
- Therapeutic Procedures
- Medical Imaging
- Healthcare Technology
- Medical Robotics
- Surgical Instruments
- Patient Care
- Medical Device Manufacturing
Support Channels
System Requirements
Compatible ultrasound imaging systems
Target Users
- clinicians
- surgeons
- urologists
- nephrologists
- interventional radiologists
- medical device manufacturers
- healthcare providers
- patients
- medical institutions
- healthcare administrators
Training Options
Type
product
User Reviews
Version
1.0