SLEEP SYSTEM FOR CLINICS & RESEARCH
Overview
Compumedics Limited is a global leader in the development, manufacture, and commercialization of diagnostic technologies for sleep, brain, and ultrasonic blood-flow monitoring applications. Established in 1987, the company has focused on developing comprehensive solutions for sleep diagnostics, ranging from high-definition 4K full Polysomnography (PSG) to portable home sleep testing (HST) devices. Their offerings include advanced PSG/EEG amplifiers like the Grael 4K PSG:EEG, multi-purpose Somté PSG, and ambulatory recording devices such as the Siesta System.
The core of their software solutions is the Profusion Sleep software suite, designed for high-throughput sleep labs and advanced research environments, enabling real-time PSG recording, high-resolution data acquisition, and comprehensive analysis. This platform supports various scoring protocols (AASM, Rechtschaffen & Kales) and integrates workflow management for patient demographics, study acquisition, scoring, reporting, and data archiving. Compumedics also offers web-based patient data and lab management systems like ProFusion neXus 360, which provides integrated hardware and software solutions for both Sleep and Neurology clinics. The company is committed to quality, adhering to globally recognized quality assurance systems and medical device regulatory requirements including FDA (USA), CE Mark (Europe), TGA (Australia), ISO 13485, and ISO 27001.
While Compumedics is dedicated to data safety and security, and its employees undergo HIPAA training, the company experienced a data security incident in 2025 that impacted patient protected health information (PHI) for some healthcare provider clients.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- High-definition 4K PSG/EEG amplification technology (Grael 4K PSG:EEG)
- Comprehensive Profusion Sleep software suite for acquisition, scoring, and analysis
- Support for AASM, Rechtschaffen & Kales, and custom scoring protocols
- Real-time high-fidelity data capture across multiple physiological channels (EEG, EOG, EMG, ECG, respiratory, limb movement)
- Integrated workflow management for patient demographics, study acquisition, reporting, and archiving
- Automated detection algorithms for sleep events (apneas, hypopneas, desaturations, PLMs, arousals)
- Multi-monitor and multi-study review capabilities
- Scalable architecture for standalone or full-lab environments with HL7 integration for EMR systems
- Home Sleep Testing (HST) solutions (Somtu00e9, Somfit, Falcon HST)
- Cloud-based data management and lab management system (ProFusion neXus 360)
Use Cases
- Clinical diagnosis of sleep disorders
- Advanced sleep research studies
- In-lab polysomnography (PSG)
- Home sleep testing (HST)
- Ambulatory PSG
- Neurology diagnostics and brain research
What Physicians Need to Know
Leverage the automated scoring and advanced event detection features to streamline diagnosis and reduce manual review time, while ensuring compliance with AASM and other clinical standards. Utilize the comprehensive data capture across various physiological channels for a holistic view of sleep architecture and respiratory events, aiding in precise diagnosis and treatment planning for sleep disorders. Integrate the system with existing EMR/LIS via HL7 to ensure seamless data flow, reduce administrative burden, and maintain a centralized patient record for improved workflow efficiency and patient management. Consider the system's scalability and multi-site management capabilities for expanding sleep diagnostic services or managing multiple lab locations effectively.
Compumedics' sleep systems, particularly through the Profusion neXus LMS and Profusion neXus 360 platforms, offer robust integration capabilities. They support HL7 for bi-directional communication with hospital EMR/HIS systems, facilitating the exchange of patient demographics, scheduling information, orders, and final reports. The software is designed to integrate seamlessly with Compumedics' own hardware and is scalable for various lab environments, from standalone to multi-site operations.
Details
| Category | Lab & Diagnostics, Neurology AI, Wearables & Remote Monitoring (RPM) |
| Pricing | Contact for pricing — Pricing is not publicly disclosed; contact Compumedics sales for detailed quotations. |
| Deployment | On-premise; Cloud-based (for data management systems like Profusion neXus 360) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The Compumedics Sleep Monitoring System received FDA 510(k) clearance (K955841) on March 11, 1997. This system functions as an information management tool to record, display, organize, summarize, retrieve, and generate user-defined reports based on physiological data from monitoring devices used to evaluate sleep and sleep-related respiratory disorders. More recently, Compumedics also received FDA 510(k) clearances for its Somfit (2023) and Somfit-D (2025) home sleep monitoring devices. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurology, Pulmonology, Sleep Medicine |
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