FOR IMMEDIATE RELEASE
Nerbio’s iTOF® Receives FDA Clearance as First App-Controlled Neuromuscular Blockade Monitor
San Jose, CA — 06/04/2025 — Nerbio, a leader in intelligent patient monitoring solutions, proudly announces that its iTOF® device has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This milestone marks iTOF as the world’s first wireless, app-controlled quantitative neuromuscular blockade (NMB) monitoring device to achieve FDA clearance
Designed to modernize perioperative care, the iTOF system integrates a Bluetooth-enabled nerve stimulator with a user-friendly mobile application, offering clinicians precise, real-time monitoring of neuromuscular function. The device supports multiple stimulation modes, including Train-of-Four (TOF), Post-Tetanic Count (PTC), and Double Burst Stimulation (DBS), ensuring comprehensive assessment capabilities.
Key Benefits of iTOF:
Enhanced Efficiency: Clinical use of iTOF has demonstrated a 10% improvement in operating room turnover and a 30% reduction in the use of neuromuscular blockers and reversal agents.
Improved Patient Safety: Hospitals report up to 70% fewer residual blockade complications, aligning with American Society of Anesthesiologists (ASA) guidelines.
Cost-Effective Solution: With a subscription model as low as $1 per day, iTOF eliminates disposable costs and capital expenditures, offering a full replacement warranty.
AI-Assisted Monitoring: The system features voice-guided prompts and AI-driven assistance, enhancing decision-making and reducing the potential for human error.
“The FDA clearance of iTOF represents a significant advancement in neuromuscular monitoring,” said Henry Sullivant, Chief Executive Officer at Nerbio. “Our goal is to provide clinicians with accessible, accurate, and intelligent tools that enhance patient outcomes and streamline perioperative workflows.”
iTOF is currently in use across various international healthcare settings, including hospitals in Chile, Colombia, and India, with over 50,000 cases reported. The device’s portability, ease of use, and integration capabilities make it a valuable asset in both operating rooms and critical care units.
About Nerbio Medical Software Platforms, Inc.:
Nerbio is a medical technology company that is revolutionizing critical care monitoring through the development of compact, wireless app-controlled devices utilizing advanced sensor technology, AI-powered assistance and intelligent mobile connectivity. With its international headquarters in San Jose, CA, and U.S. sales operations based in Memphis, TN, Nerbio is dedicated to transforming the delivery of critical care worldwide.
Relevant Links:
FDA 510(k) clearance
FDA 510(k) clearance summary PDF
LinkedIn
Introduction To Nerbio iTOF Video
Media Contact:
Ken Leonard
Chief Innovation Officer
Nerbio Medical Software Platforms, Inc.
Phone: +1 (408) 809 3296
Email: media@nerbio.com
For more information, visit www.nerbio.com.
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