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EnsoData

FDA-cleared AI software for sleep disorder diagnosis and therapy monitoring

United States
51-200 employees
Verified
1 Cert

About EnsoData

EnsoData develops FDA-cleared software as medical devices (SaMD) focused on sleep disorder diagnosis and therapy management. The company offers a suite of AI-powered solutions including EnsoSleep for automated scoring of polysomnography (PSG) and home sleep apnea tests (HSAT), EnsoHST for multi-night home sleep testing using comfortable wearable devices, and Therapy Track for long-term therapy monitoring and titration.

The platform processes physiological signals including photoplethysmography (PPG), SpO2, pulse, snore, acoustic flow, position, HRV, and actigraphy to detect sleep apnea and other sleep disorders. EnsoSleep's AI scoring achieves 93% overall AHI agreement, 94% sleep-disordered breathing agreement, and 86% sleep staging agreement, while delivering average time savings of 62% on PSGs and 68% on HSATs. The cloud-based study management platform centralizes workflow across devices, locations, and clinical teams.

EnsoData serves over 500 U.S. sleep centers and recently raised $20 million in Series B funding to expand commercial operations. The company targets the estimated 54 million Americans with sleep apnea, 80% of whom remain undiagnosed.

Best For

Sleep centers, hospital sleep labs, and health systems looking to increase diagnostic capacity and reduce scoring time through AI automation. Organizations seeking to expand home sleep testing programs with multi-night testing capabilities and integrate therapy monitoring into their sleep disorder management workflows.

Key Strengths

  • FDA-cleared AI scoring with 93% AHI agreement and documented 62-68% time savings on sleep study scoring
  • Comprehensive platform connecting diagnosis through therapy with EnsoHST, EnsoSleep, Celeste+, and Therapy Track
  • Multi-night home sleep testing (up to 7 nights) using comfortable ring and watch form factors to reduce night-to-night variability
  • Cloud-based platform enabling centralized management across multiple locations and teams
  • Strong customer base with 500+ U.S. sleep centers and extensive testimonials from sleep lab directors and clinical staff
  • Support for 8+ physiological signals including PPG, SpO2, pulse, snore, acoustic flow, position, HRV, and actigraphy

Why Choose EnsoData

Sleep centers should consider EnsoData when seeking to scale diagnostic capacity without proportionally increasing clinical staff, particularly organizations facing sleep technologist shortages or wanting to expand beyond traditional lab-based testing. The platform's strength lies in its comprehensive approach, covering the full patient journey from home-based testing through AI-assisted scoring to therapy monitoring and titration.

Expect a cloud-based implementation that centralizes study management across facilities and enables remote workflow management. The AI scoring delivers consistent results while allowing clinical oversight and editing, making it suitable for organizations prioritizing quality alongside efficiency gains.

Healthcare Focus

EnsoData operates exclusively in sleep medicine, providing FDA-cleared medical device software specifically for sleep disorder diagnosis and therapy management. The company addresses clinical workflow challenges in sleep centers and hospital sleep labs, with solutions designed around polysomnography scoring standards, home sleep apnea testing protocols, and therapy monitoring for CPAP, GLP-1s, hypoglossal nerve stimulation (HGNS), and oral appliances. The platform supports sleep medicine professionals including sleep physicians, registered polysomnographic technologists (RPSGTs), and respiratory therapists in managing obstructive sleep apnea and related sleep disorders.

Ideal Client Profile

Mid-to-large sleep centers and health systems with multiple testing locations seeking to optimize operational efficiency through AI automation. Organizations looking to expand home sleep testing programs while maintaining clinical quality, or those wanting to add therapy monitoring capabilities to support value-based care models and improve patient outcomes post-diagnosis.

Specializations

AI-powered sleep disorder diagnosis Photoplethysmography (PPG) analysis Polysomnography (PSG) automated scoring Home sleep apnea testing (HSAT) Sleep therapy monitoring and titration Cloud-based sleep study management Remote patient monitoring for sleep disorders

Client Types

Hospitals Health Systems Digital Health Medical Devices

Why Choose EnsoData?

  • 51-200 team members
  • 1 certification verified
  • Select Partner on Curatrix
  • Verified on Curatrix

Quick Facts

Headquarters
United States
Company Size
51-200 employees

Certifications

fda 510(k)

Profile last updated: Jan 25, 2026

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