SANSA HSAT
Overview
SANSA HSAT by Huxley Medical is an FDA-cleared, chest-worn diagnostic patch designed to streamline the evaluation of sleep-related breathing disorders, including Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), in adults. Unlike traditional home sleep apnea tests, SANSA HSAT offers an app-free workflow, utilizing cellular data upload to transmit physiological data directly to physicians, eliminating the need for Bluetooth pairing or smartphone applications. The device integrates a reflective photoplethysmography (PPG) sensor, a single-lead electrocardiogram (ECG) sensor, and a 3-axis accelerometer to measure nine physiological data channels: blood oxygen saturation (SpO2), heart rate, respiratory effort, chest movement, ECG, body position, actigraphy, snoring, and sleep/wake staging. It employs AI-powered auto-scoring to generate automated, customizable reports on the Huxley HUB™ software portal, aiding physicians in diagnosis and treatment planning. SANSA HSAT is designed to enhance practice efficiency, reduce patient calls, and eliminate testing backlogs by offering scalable, direct-to-patient test delivery and 24/7 live support.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Chest-worn diagnostic patch for home use
- App-free workflow with cellular data upload
- AI-powered auto-scoring for automated reports
- Measures 9 physiological data channels (SpO2, Heart Rate, Respiratory Effort, Chest Movement, ECG, Body Position, Actigraphy, Snoring, Sleep/Wake Staging)
- FDA-cleared for Obstructive and Central Sleep Apnea detection
- Eliminates wires, belts, hoses, or additional attachments
- Direct-to-patient test delivery
- 24/7 live support
- Customizable report templates
Use Cases
- Diagnosis of Obstructive Sleep Apnea (OSA)
- Diagnosis of Central Sleep Apnea (CSA)
- Streamlining home sleep apnea testing for healthcare providers
- Reducing patient calls and clinic visits for sleep disorder diagnosis
- Enriching cardiosleep management with comprehensive data
- Assessing cardiac rhythm with ECG during sleep testing
What Physicians Need to Know
SANSA HSAT offers a streamlined approach to diagnosing obstructive sleep apnea (OSA) and detecting cardiac arrhythmias from home, integrating cardiosleep assessments into a single, easy-to-use chest patch. Its app-free cellular data upload simplifies the patient experience and provides rapid access to automated reports and physiological tracings for efficient review and diagnosis. This can significantly reduce testing backlogs and enhance diagnostic capabilities, particularly for patients with comorbid cardiac conditions. The device's FDA clearance and validation against gold-standard polysomnography ensure reliable diagnostic performance across diverse populations.
The SANSA HSAT system operates on Huxley HUBu2122, a cloud-native platform designed to modernize workflows. This platform provides a secure, HIPAA-compliant, web-based user interface for seamless patient workflow management. Data is accessible anywhere, anytime, with real-time re-scoring capabilities and customizable report templates. Sleep and ECG reports are delivered directly to respective specialists post-review and interpretation.
Details
| Category | Neurology AI, Wearables & Remote Monitoring (RPM) |
| Pricing | Not disclosed — Not disclosed |
| Deployment | Device-based, with data uploaded to a cloud-based software portal (Huxley HUB™) for physician review. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated SANSA HSAT has received multiple FDA 510(k) clearances. The latest clearance (K252497, December 10, 2025) added the ability to classify between Obstructive and Central Sleep Apnea events using an AI/ML classifier. Previous clearances include cellular data upload (February 5, 2025) and initial clearance for sleep apnea testing (July 2024). |
| Integrations | |
| EHR | Not specified |
| Specialties | Otolaryngology (ENT), Pulmonology, Sleep Medicine |
What the Web Says
The SANSA HSAT by Huxley Medical is a wearable home sleep apnea test designed to evaluate sleep-related breathing disorders in adults. It's a prescription-only device intended for use in both clinical and home settings under the direction of a healthcare professional. The device utilizes a single chest-worn patch with PPG, ECG, and accelerometer sensors, and its data is analyzed by a cloud-based AI/ML algorithm to provide clinicians with time-series data and summary metrics.
Overall: PositiveStrengths
- Comparable accuracy to in-laboratory polysomnography (PSG) for detecting moderate-to-severe OSA.
- Simplified application and patient training due to a single point of contact on the chest, eliminating multiple belts, wires, and tubes.
- Familiar Holter monitor-like design may encourage interdisciplinary collaborations with cardiologists and primary care physicians.
- High sensitivity across all OSA severity categories and reliable performance across all skin tones.
- Captures nine physiological channels without failure-prone wires, belts, finger probes, or nasal cannulas.
- Data uploads automatically over integrated cellular, removing the need for smartphones, Bluetooth, or pairing.
Limitations
- Specificity decreased at lower AHI cutoffs, consistent with other home sleep testing devices.
- The ECG channel is for reference only and not for automated ECG analysis or pacemaker analysis.
- Requires review and event editing by a qualified healthcare professional.
- Prescription-use only.
Based on reviews from: Medical Management of Obstructive Sleep Apnea Syndrome, Validation Study of SANSA Home Sleep Apnea Test Published in Frontiers in Neurology, Huxley Medical Announces | Patient Care Online, July 15, 2024 Huxley Medical Grace Powers Founder - accessdata.fda.gov, Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome - Blue Cross and Blue Shield of Kansas, October 29, 2025 Huxley Medical Grace Powers Founder - accessdata.fda.gov, Huxley SANSA Home Sleep Apnea Test (1000-00) (K240285) u2014 FDA 510(k) | Innolitics, SANSA Sleep Apnea Diagnostic Patch Cleared By FDA - SleepWorld Magazine, Peer-Reviewed Study Validates Accuracy of SANSA Home Sleep Apnea Test, January 28, 2025 Huxley Medical u2105 Grace Powers Founder - accessdata.fda.gov, Sleep apnea test | SANSA by Huxley
Last updated: 2026-07-18
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