{"product_name":"Steth IO","company_name":"Steth IO","product_url":"https://stethio.com","company_url":"https://stethio.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0623","summary":"Steth IO offers a smartphone-based stethoscope that enables healthcare providers to listen to, visualize, and record heart and lung sounds, enhancing diagnostic accuracy and patient engagement.","description":"Steth IO's device integrates into a smartphone case, transforming it into a digital stethoscope. It captures heart and lung sounds, providing real-time visualizations and recordings through its accompanying app. The device is FDA-cleared and requires no batteries or charging, drawing power directly from the smartphone. It is compatible with iPhone models 6 and higher. The app is available for free on the App Store. The device was launched in April 2018 and is priced at $199. An AI assistant feature was introduced in November 2018 to assist doctors in analyzing heart sounds. The company was founded in 2015 and is based in Bothell, Washington, USA. As of 2018, the company had raised $1.23 million in funding. The device is currently available for iPhone users, with no Android version announced. The company has not publicly disclosed its licensing terms. The device is intended for use by healthcare providers, including physicians and cardiologists, to improve the detection and diagnosis of heart and lung conditions. The device is available in the United States and has been cleared by the FDA for medical use. The app and device are available in English. The pricing model is a one-time purchase of $199 for the device, with the app available for free. The company was founded in 2015 and is based in Bothell, Washington, USA.","categories":["clinical Care","diagnostic Support","patient Facing","mobile Health","telehealth","remote Monitoring","medical Device","ai Clinical Documentation Integrity","clinical Decision Support","cardiology","Clinical","Diagnostic","Patient-facing","Mobile Health","Telemedicine","Remote Patient Monitoring","Medical Devices","Artificial Intelligence","Cardiology","Pulmonology"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Physicians","Cardiologists","Pulmonologists","Nurses","Medical Students","Patients"],"specialties":["Cardiology","Pulmonology","Family Medicine","Internal Medicine","Emergency Medicine","Pediatrics","Geriatrics","Obstetrics And Gynecology","Orthopedics","Neurology","Rheumatology","Endocrinology","Gastroenterology","Hematology","Oncology","Infectious Diseases","Dermatology","Psychiatry","Anesthesiology","Pathology"],"regions_available":["United States","Canada","European Union","Australia","New Zealand","United Kingdom","India","China","Japan","South Korea","Brazil","Mexico","South Africa","Saudi Arabia","United Arab Emirates","Israel","Turkey","Russia","South America","Southeast Asia"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati"],"pricing_model":"Subscription","pricing_details":"The device is available for a one-time purchase of $199. The app is free to download. The AI assistant feature was introduced in November 2018 and was free during its beta testing phase. For the most current pricing and subscription options, please visit the official website.","license":"Commercial","company_offices":["United States","Canada","European Union","Australia","New Zealand","United Kingdom","India","China","Japan","South Korea"],"company_founding":"2015","deployment_model":["SaaS"],"os_platforms":["iOS"],"features":["Real-time visualization of heart and lung sounds","Integration with smartphone for data capture","Recording and organizing patient examinations","Exporting and sharing examination recordings","Digital filters to enhance important frequencies and reduce background noise","Artificial intelligence assistant for heart sound analysis"],"optional_modules":["Remote patient monitoring","Telemedicine platform integration","Patient compliance notifications","Cloud-based cardiopulmonary examination"],"integrations":["Webex by Cisco"],"data_standards":["HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"iPhone 6 or higher","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance"],"security_features":["Encryption","Audit logs","2FA"],"privacy_features":["BAA available","Consent management","Data anonymization","Data minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0623","slug":"steth-io","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/steth-io.json"}}