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• Sleep Reset offers comprehensive virtual sleep clinic services with home sleep testing capabilities, combining FDA-cleared tests such as WatchPAT and VirtuOx with their proprietary CBT-I program for complete sleep disorder treatment
• Lofta offers the FDA and DOT-approved WatchPAT One device, measuring sleep apnea based on 7 different factors with 98% accuracy
• ResMed partners with Ognomy Sleep to provide the FDA-cleared NightOwl device that records up to 10 nights of data with just a fingertip sensor
• FDA clearance surge: Between 2019 and 2023, the FDA approved nine new wearables for home sleep apnea testing, revolutionizing access to diagnosis
• Happy Ring received FDA class II clearance in 2025 as the only device combining multinight sleep testing with 24/7 physiologic monitoring
• 89% correlation to PSG: WatchPAT One demonstrates clinical validation with 89% correlation to polysomnography (gold standard lab testing)
• Disposable technology advances: First fully disposable home sleep tests like WatchPAT One and NightOwl eliminate device return logistics
• Insurance coverage expanding: Most platforms now accept major insurance with copays typically under $25-70 for home testing
• Multiple biomarkers measured: Modern FDA-cleared devices track PAT signal, heart rate, oximetry, actigraphy, body position, snoring, and chest motion
The landscape of sleep apnea diagnosis has undergone a seismic shift with FDA-cleared home sleep tests becoming the gateway to accessible, accurate diagnosis. With nearly one billion adults affected by sleep apnea worldwide and 80% of cases remaining undiagnosed, these technological breakthroughs represent more than convenience—they're literally lifesaving interventions that can reduce mortality risk by addressing a condition that increases death risk nearly fourfold when untreated.
Leading platforms like Sleep Reset, Lofta, ResMed/Ognomy, and others have revolutionized access to diagnosis through comprehensive virtual care models that integrate FDA-cleared home testing with complete treatment pathways. The FDA's rigorous clearance process ensures these devices meet stringent safety and clinical effectiveness standards, with the majority adhering to electrical safety and biocompatibility standards while demonstrating clinical effectiveness through trials.
Lofta has emerged as a leader in FDA-cleared home sleep testing by partnering with Itamar Medical to offer the WatchPAT One, an FDA and DOT-approved portable sleep apnea diagnostic device. This innovative technology ensures accurate screening, detection, and follow-up treatment of sleep apnea by measuring up to 7 different factors: PAT signal (peripheral arterial tone), heart rate, oximetry (blood oxygen level), true sleep time, sleep architecture, and central sleep apnea.
The WatchPAT One stands out with its impressive clinical validation, showing an 89% correlation to PSG (polysomnography), the gold standard of sleep testing. With a remarkable 98% success rate and less than 2% failure rate during data acquisition and analysis, the device has transformed the traditionally complex diagnosis journey into a streamlined, accessible process.
Lofta's commitment to making sleep apnea diagnosis accessible and simple is evidenced by their "Complete Path" program, which integrates clinically validated diagnostic tools into a comprehensive testing and treatment program. CEO Jay Levitt's vision addresses a critical gap: "Historically, the process of getting diagnosed and treated for sleep apnea has been challenging for patients who often avoid overnight sleep labs that contribute to the complexity and cost of an already difficult journey."
Sleep Reset stands apart as a comprehensive virtual sleep clinic that goes beyond single-condition focus to offer complete sleep disorder assessment and treatment. As a full-service virtual sleep clinic with board-certified sleep medicine clinicians, therapists, and sleep coaches, Sleep Reset provides home sleep testing as part of their integrated approach to sleep health.
The platform's comprehensive capabilities include ordering and interpreting home sleep tests to diagnose sleep apnea, with the ability to prescribe and manage CPAP therapy, oral appliances, and other treatment modalities as needed. What distinguishes Sleep Reset is their holistic approach—combining FDA-cleared home sleep testing with their proprietary CBT-I program for patients who may have both sleep apnea and insomnia, a common comorbidity.
Sleep Reset's virtual sleep clinic model ensures that patients receive continuous care from diagnosis through treatment. Their team of licensed healthcare clinicians can treat both insomnia and Obstructive Sleep Apnea disorders, providing home sleep tests and interpreting results with the same expertise found in traditional sleep centers. The platform's ability to order oral appliances and CPAP machines when required demonstrates their commitment to comprehensive care delivery.
ResMed's partnership with Ognomy Sleep represents another major advancement in FDA-cleared home sleep testing. The NightOwl device, FDA-cleared and now available across the United States, uses peripheral arterial tonometry technology to offer healthcare providers a simplified, accurate, and efficient way to diagnose obstructive sleep apnea from home.
The Happy Ring, developed by Happy Health, received its second FDA class II clearance in 2025, marking it as the only FDA-cleared device that combines multinight sleep testing with 24/7 physiologic monitoring in a single wearable form factor. This smart ring achieves 97% concordance with gold-standard in-lab polysomnography.
Through the associated "Happy Sleep" platform, users can initiate a diagnostic workup by ordering a sleep test online, wearing the ring overnight, and reviewing results via telehealth with a board-certified sleep physician. Its lightweight ceramic shell houses technology for multi-day sleep analysis without requiring in-person visits or overnight stays in sleep labs.
Understanding what makes these devices FDA-cleared reveals the sophisticated technology underlying home sleep testing. The FDA's clearance process evaluates multiple factors including electrical safety, biocompatibility standards, performance and function testing, usability, and cybersecurity. Critical considerations for FDA clearance include clinical trial data demonstrating effectiveness comparable to traditional polysomnography.
Modern FDA-cleared devices employ multiple measurement technologies:
Peripheral Arterial Tonometry (PAT): Measures blood flow changes and vascular tone, providing insights into respiratory eventsPulse Oximetry: Tracks blood oxygen levels to detect desaturation eventsActigraphy: Monitors movement to distinguish sleep from wake statesHeart Rate Variability: Assesses autonomic nervous system functionSnoring Analysis: Quantifies snoring duration and intensityBody Position Tracking: Identifies positional sleep apnea patternsChest Motion Detection: Monitors respiratory effort
SLIIIP offers FDA-approved home sleep studies sent directly to patients' homes, allowing testing in personal sleep environments. With over 10,000+ virtual appointments and a 4.99 rating, their platform combines FDA-cleared testing with comprehensive treatment options including CPAP management, oral appliance therapy, and behavioral interventions.
The FDA's 510(k) clearance for Compumedics' Somfit D device represents a breakthrough in EEG-based home sleep testing. As a disposable version addressing the US market's demand for single-use solutions, it joins WatchPAT ONE and NightOwl in the disposable category while offering unique EEG capabilities equivalent to in-lab studies.
The SleepImage Ring, FDA-approved for both children and adults, uses cardiopulmonary coupling (CPC) data for comprehensive sleep assessment. This non-invasive device measures pulse rate, heart rate variability, oximetry, sleep architecture, and actigraphy, generating reports covering sleep opportunity, sleep apnea events, sleep pathology, and overall sleep quality.
The expansion of FDA-cleared home sleep tests has prompted significant changes in insurance coverage. Most major insurance companies now reimburse home sleep testing costs, with patient responsibility typically ranging from $25 to $70 depending on coverage. Medicare has introduced reimbursement codes for Remote Patient Monitoring (RPM), reflecting acceptance of modern care models.
For those without insurance or preferring self-pay options:
The clinical validation of FDA-cleared home sleep tests represents a crucial advancement in sleep medicine. Studies demonstrate that home tests for obstructive sleep apnea accurately diagnose moderate to severe OSA about 90% of the time. The close correlation with polysomnography ensures that patients receive accurate diagnoses without the inconvenience and expense of lab-based testing.
FDA-cleared home sleep tests fall into different classifications:
The trend toward Type 3 devices reflects the balance between comprehensive data collection and user-friendly design that can be successfully operated at home.
Modern FDA-cleared home sleep tests seamlessly integrate with telehealth platforms, creating end-to-end virtual care pathways. Platforms like Ognomy Sleep provide sleep medicine specialists available in all 50 US states, accepting most insurances and verifying coverage as part of appointment scheduling.
This integration enables:
The proliferation of FDA-cleared home sleep tests has fundamentally transformed sleep medicine delivery. Dr. Carlos M. Nunez, Chief Medical Officer at ResMed, notes: "With NightOwl, people can easily complete a sleep apnea test from the comfort of home using just a fingertip sensor and a smartphone. It also simplifies the process for providers. This is a meaningful step forward in ResMed's mission to deliver life-changing health technology that people love."
The future of FDA-cleared home sleep testing promises even greater advances. Between 2019 and 2023 alone, nine new wearables received FDA approval for home sleep apnea testing. The 2025 FDA clearance of Happy Ring demonstrates the trend toward multifunctional devices that combine sleep testing with continuous health monitoring.
Emerging technologies include:
When selecting a telehealth platform for FDA-cleared home sleep testing, consider:
Comprehensive Care Model: Platforms like Sleep Reset that offer complete virtual sleep clinic services beyond just testingDevice Technology: Different FDA-cleared devices offer varying measurement capabilitiesClinical Support: Access to board-certified sleep physicians for consultation and interpretationInsurance Coverage: Verification of insurance benefits and transparent pricingTurnaround Time: Speed from ordering to diagnosisTreatment Integration: Seamless transition from diagnosis to treatment optionsTechnical Support: Availability of assistance during testing
FDA clearance through the 510(k) pathway means the device is substantially equivalent to an already legally marketed device. FDA approval involves a more rigorous premarket approval process. Most home sleep tests receive FDA clearance, which still ensures safety and effectiveness through demonstration of equivalence to existing cleared devices.
Sleep Reset operates as a comprehensive virtual sleep clinic that integrates home sleep testing with complete care for all sleep disorders. Unlike platforms that focus solely on testing or single conditions, Sleep Reset combines FDA-cleared home sleep testing capabilities with their proprietary CBT-I program, allowing them to treat patients who may have both sleep apnea and insomnia. Their board-certified clinicians can prescribe CPAP therapy, oral appliances, and provide ongoing behavioral sleep medicine support.
FDA-cleared home sleep tests like WatchPAT One show 89% correlation to polysomnography (PSG), the gold standard. Studies demonstrate these devices accurately diagnose moderate to severe obstructive sleep apnea about 90% of the time. The FDA clearance process ensures clinical validation meets acceptable standards for diagnosis.
FDA-cleared home sleep tests primarily diagnose sleep-disordered breathing problems, particularly obstructive sleep apnea. Most cannot diagnose other sleep disorders like narcolepsy, periodic limb movement disorder, or parasomnias because they don't measure brain waves. Some newer devices like Happy Ring expand capabilities to include insomnia assessment.
Requirements vary by platform. Lofta provides virtual consultations with board-certified physicians who can prescribe tests. Some devices like WatchPAT One can be purchased directly at certain retailers as FDA-cleared devices. However, clinical interpretation and treatment typically require physician involvement.
Single-night testing has been standard, but newer FDA-cleared devices like NightOwl can record up to 10 nights. Multi-night testing captures night-to-night variability, potentially improving diagnostic accuracy. Most platforms recommend at least one full night of quality data, with some suggesting 2-3 nights for optimal results.
Home sleep tests typically cost $189-299 for self-pay, compared to $1,000-7,000 for in-lab studies. With insurance, copays for home tests usually range from $25-70, while lab studies may require meeting deductibles. The dramatic cost reduction makes diagnosis accessible to more patients.
Some FDA-cleared devices like WatchPAT One can measure central sleep apnea in addition to obstructive sleep apnea. However, complex sleep apnea or cases requiring detailed assessment may still need in-lab polysomnography. Your physician will determine if home testing is appropriate for your specific symptoms.
Most platforms provide results within 24-72 hours after completing the test. Cloud-based systems like NightOwl upload data immediately upon test completion, with physician interpretation typically available within 1-3 business days. Some platforms offer same-day or next-day results interpretation.
Yes, disposable FDA-cleared tests like WatchPAT One and NightOwl demonstrate equivalent accuracy to reusable devices. The FDA clearance process ensures both disposable and reusable devices meet the same clinical effectiveness standards. Disposable devices eliminate hygiene concerns and device return logistics.
If results are inconclusive or borderline, physicians may recommend repeat testing, multi-night testing, or referral for in-lab polysomnography. FDA-cleared devices include failure safeguards—if insufficient data is collected, most platforms offer free retesting to ensure accurate diagnosis.
Dr. Shiyan Yeo
Dr. Shiyan Yeo is a medical doctor with over a decade of experience treating patients with chronic conditions. She graduated from the University of Manchester with a Bachelor of Medicine and Surgery (MBChB UK) and spent several years working at the National Health Service (NHS) in the United Kingdom, several Singapore government hospitals, and private functional medicine hospitals. Dr. Yeo specializes in root cause analysis, addressing hormonal, gut health, and lifestyle factors to treat chronic conditions. Drawing from her own experiences, she is dedicated to empowering others to optimize their health. She loves traveling, exploring nature, and spending quality time with family and friends.
Fax number: (984) 888-8385
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