{"product_name":"Falcon HST","company_name":"Compumedics","product_url":"https://www.compumedics.com.au/en/products/falcon-hst-2/","company_url":"https://www.compumedics.com.au","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0094","summary":"Falcon™ HST is a home sleep testing device by Compumedics, designed for efficient patient self-setup and comprehensive sleep diagnostics.","description":"Falcon™ HST is a fully integrated home sleep testing solution that offers intuitive patient setup, comprehensive data acquisition, and seamless reporting. It includes both disposable and reusable sensor options, and utilizes the Profusion PSG software suite for data analysis and reporting. The device has received FDA clearance for marketing in the USA and has been successfully launched in Australia, with plans for expansion into the U.S. market. ([compumedics.com.au](https://www.compumedics.com.au/en/asx-announcements/business-update-mar5-2025/?utm_source=openai))","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","patients","admins"],"specialties":["Sleep Medicine","Cardiology"],"regions_available":["Australia","United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["Australia","United States","Germany"],"company_founding":"1987","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android"],"features":["Integrated color touch screen for simple user interface and patient set-up","Integrated battery and simple charging station","Charging station incorporates USB for data transfer","Integrated Bluetooth for data transfer","High-resolution and quality signal capabilities","Color-coded head leads match Falcon unit connectors","Four high-speed channels: two bi-polar, one bipolar with key, one ECG channel","Two inductive band channels with dedicated disposable or reusable bands","256 samples per second, 24 bits, DC coupled","Airflow measurement","Oximetry"],"optional_modules":["Cloud integration","Local software integration"],"integrations":["Cloud services","Local software"],"data_standards":["HL7","DICOM"],"api_available":"unknown","system_requirements":"Web browser, iOS or Android device","compliance":["HIPAA","FDA 510(k)"],"certifications":["FDA 510(k)"],"security_features":["Encryption","Audit logs","2FA"],"privacy_features":["BAA available","Consent management","Data anonymization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0094","slug":"falcon-hst","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/falcon-hst.json"}}