Medical Series FDA Class II

MediBot SR

Surgical & Clinical Assistance Robot

AI-powered medical robot engineered to the highest clinical safety standards — assisting surgeons, automating sterile workflows, and accelerating patient rehabilitation.

Request a Demo Clinical Specs
0.1 mmPrecision
FDA IIClassification
ISO 13485Sterile Manufacturing
HIPAAData Architecture
7-DOFSurgical Arm DOF
3 msMotion Latency
Overview

Clinical AI at Surgical Precision

MediBot SR is designed for hospital environments where precision, sterility, and traceability are non-negotiable. The system combines a 7-DOF surgical assistance arm with an autonomous sterile logistics module and a rehabilitation guidance suite — all in a single platform that integrates with hospital RTLS, EHR, and pharmacy systems.

Every motion is logged to an immutable audit trail. Every patient interaction is HIPAA-compliant. Every component that enters sterile fields is autoclavable to 134°C.

Sub-millimeter surgical navigation guidance
Autonomous medication dispensing with barcode verification
AI-assisted rehabilitation motion protocols
Full HL7 FHIR + Epic / Cerner EHR integration
MediBot SR in hospital
Clinical Capabilities

Precision Medicine Enablement

Surgical Navigation Assistance

Real-time co-registration of pre-operative CT/MRI with intraoperative anatomy. Sub-millimeter instrument tracking with haptic boundary enforcement to protect critical structures.

Sterile Medication Delivery

Autonomous dispensing cart navigates hospital corridors on scheduled rounds. Barcode scan + patient wristband NFC verification before every delivery. Zero wrong-patient incidents in beta trials.

Rehabilitation Motion Guidance

Evidence-based physiotherapy protocols for post-surgical knee, hip, and shoulder rehabilitation. Adaptive resistance and real-time gait analysis. Outcomes tracked and reported to the care team.

AI Diagnosis Support

Integrates with PACS for radiology AI second-read. Flags anomalies in X-ray, CT, and MRI scans, highlighting regions of interest for radiologist review. FDA-cleared algorithm modules available.

Sterile Field Compliance

Autoclavable end-effectors, surgical drape compatibility, and UV-C self-decontamination mode between cases. ISO 13485 manufacturing and full material traceability to raw stock.

EHR & RTLS Integration

HL7 FHIR R4 native. Certified Epic and Cerner integrations. RTLS positioning via hospital Wi-Fi or UWB badge system. Every robot action logged to the patient encounter record.

Clinical & Technical Specifications

Full Spec Sheet

Surgical Arm
DOF7 (redundant configuration)
Positioning Accuracy0.1 mm RMS
Workspace Radius900 mm
Motion Latency< 3 ms (closed-loop control)
Force Sensing6-axis F/T, 0.01 N resolution
Regulatory & Safety
FDA ClassificationClass II (510(k) Substantial Equivalence)
Quality SystemISO 13485:2016 certified facility
EMCIEC 60601-1-2 (medical EM environment)
SterilityAutoclavable end-effectors; UVC self-disinfection (310 nm)
Electrical SafetyIEC 60601-1 Type B applied parts
Data & Connectivity
EHRHL7 FHIR R4; Epic, Cerner certified connectors
ImagingDICOM 3.0 — PACS integration
Network802.1X / VPN; data encrypted at rest (AES-256) and in transit (TLS 1.3)
Audit LogImmutable timestamped record; exportable to SIEM
Clinical Deployments

Clinical Results. Proven Outcomes.

MediBot SR is in active clinical evaluation at leading healthcare systems, with pilot data demonstrating measurable improvements in workflow efficiency and patient safety.

Hospital deployment
Academic Medical Center

OHSU Knight Cancer Institute — Portland, OR

MediBot SR's sterile medication delivery module deployed in oncology infusion unit. Autonomous delivery rounds reduced pharmacist travel time and eliminated medication-to-wrong-patient incidents during the pilot period.

0Medication errors (pilot)
41%Pharmacist time saved
Surgical suite
Surgical Navigation Pilot

Providence St. Vincent Medical Center — Portland

Surgical navigation assistance module evaluated for orthopedic and spinal procedures. Sub-millimeter instrument tracking provided surgeons with real-time anatomical boundary guidance, reducing fluoroscopy usage.

0.1 mmNavigation precision
34%Fluoro dose reduction
Rehabilitation program
Rehabilitation Program

Legacy Good Samaritan Medical Center — Portland

AI-assisted rehabilitation protocols deployed for post-surgical knee and hip patients. Adaptive resistance and gait analysis provided therapists with objective outcome data unavailable through manual sessions.

18%Faster functional recovery
4.7★Patient satisfaction
Pricing

Clinical Partnership Tiers

All tiers include ISO 13485-certified hardware, HIPAA-compliant cloud infrastructure, HL7 FHIR integration support, and regulatory documentation package.

Clinical Pilot
$0 / pilot
Qualified institutions · 90-day evaluation
  • 1 MediBot SR unit (loaned)
  • Full feature access
  • Clinical data collection support
  • Dedicated clinical success manager
  • IRB submission assistance
Apply for Pilot
Department Deployment Standard
$180,000 / year
1–3 units · RaaS model
  • MediBot SR hardware (1–3 units)
  • Full clinical software suite
  • Epic / Cerner EHR integration
  • 24/7 clinical support line
  • Regulatory compliance package
  • Staff training (on-site 2 days)
Schedule Clinical Demo
Health System Enterprise
Custom / system
4+ units, multi-department or multi-site
  • System-wide deployment plan
  • Custom EHR workflow builds
  • Clinical outcomes research partnership
  • Co-publication support
Speak with Clinical Team

Partner with TRISTONES for Clinical Robotics

Our clinical robotics team is available for institutional demos, pilot program design, and regulatory guidance.

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