{"product_name":"DeepRESP","company_name":"Nox Medical","product_url":"https://noxmedical.com/deepresp","company_url":"https://noxmedical.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0072","summary":"DeepRESP is a cloud-based AI software developed by Nox Medical to assist clinicians in diagnosing sleep disorders by analyzing sleep study recordings, including EEG signals, to automatically detect events, calculate parameters like the Apnea-Hypopnea Index, and infer sleep stages, thereby enhancing diagnostic efficiency and accuracy.","description":"DeepRESP is an FDA-cleared Software-as-a-Medical-Device (SaMD) that processes sleep study recordings to aid in diagnosing sleep disorders. It analyzes signals from sleep studies performed in hospital, home, or ambulatory settings for adults aged 22 and older, intended for use by medical professionals. The software utilizes AI and rule-based analytic protocols to score sleep studies, providing insights into sleep staging, respiratory event scoring, and calculation of clinical parameters like the Apnea-Hypopnea Index (AHI). DeepRESP is integrated with Nox Connect, a cloud-based platform that streamlines the entire sleep diagnostics workflow, offering centralized data management, AI-assisted scoring, and real-time access to connected data. This integration enhances operational efficiency, reduces scoring time, and supports collaboration among sleep technologists, physicians, and administrative staff. DeepRESP has demonstrated non-inferiority or superiority in scoring sleep stages and respiratory events compared to predicate devices, ensuring safety and efficacy. The software is verified per IEC 62304 and FDA software validation guidance, and it operates in the Nox Cloud, which holds ISO 27001, SOC 1 Type 2, SOC 2 Type 2, and HITRUST security and compliance certifications.","categories":["clinical Care","diagnostic Support","patient Facing","administrative Operations","ai Clinical Documentation Integrity","clinical Decision Support","cloud-based Solutions","medical Device Software","healthcare It","data Security","Clinical","Diagnostic","Patient-facing","Administrative","Artificial Intelligence","Cloud-based","Medical Device Software","Sleep Medicine","Healthcare It","Data Security"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Sleep Technologists","Physicians","Administrative Staff","Medical Professionals"],"specialties":["Sleep Medicine","Pulmonology","Neurology","Cardiology","Internal Medicine","Family Medicine","Geriatrics","Pediatrics","Endocrinology","Psychiatry","Otolaryngology","Orthopedics","Rheumatology","Gastroenterology","Hematology","Oncology","Infectious Disease","Nephrology","Urology","Obstetrics And Gynecology"],"regions_available":["United States","Canada","European Union","Iceland","Australia","New Zealand","United Kingdom","Norway","Sweden","Denmark","Finland","Netherlands","Belgium","France","Germany","Italy","Spain","Portugal","Poland","Czech Republic","Slovakia"],"languages_supported":["English","Icelandic","French","German","Spanish","Italian","Dutch","Swedish","Norwegian","Danish","Finnish","Portuguese","Polish","Czech","Slovak","Hungarian","Romanian","Bulgarian","Greek","Turkish"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["Iceland","United States","Canada","United Kingdom","Germany","France","Netherlands","Sweden","Norway","Denmark"],"company_founding":"2009","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["Centralized data management","AI-assisted scoring and interpretation","Web-based scoring and interpretation","Cloud infrastructure for scalability","Real-time collaboration between sleep technologists and physicians","Secure data access and sharing","FDA-cleared AI tools for sleep study analysis"],"optional_modules":["Noxturnal Desktop","Noxturnal Web"],"integrations":["Noxturnal Desktop","Noxturnal Web"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","GDPR","ISO 27001","SOC 1 Type 2","SOC 2 Type 2","HITRUST"],"certifications":["FDA 510(k)"],"security_features":["TLS 1.2 encryption","AES-256 encryption","Audit logs","Role-based access control","Single sign-on (SSO)"],"privacy_features":["Configurable data retention aligned with HIPAA and GDPR","Data anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0072","slug":"deepresp","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/deepresp.json"}}