AcuPebble Ox100
FDA-cleared home sleep testing device for obstructive sleep apnea diagnosis
Company profile
Company profile
Acurable creates accurate and user-friendly wearable medical devices for at-home monitoring of sleep apnea, epilepsy, COPD, and asthma.
Company description Acurable official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Hybrid deployment with recorded integration context.
Company milestones
FDA clearance for AcuPebble Ox100 as Class II medical device. CE mark certification for class IIa medical device. Selected by NHS Innovation Accelerator as one of 12 innovations to scale across NHS England. Opened Spanish office in Seville (2018).
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
FDA-cleared home sleep testing device for obstructive sleep apnea diagnosis
CE-marked automated sleep apnea diagnosis device for adults
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
ERJ open research · Nov 1, 2025
Validation of Tracheal Sound-Based Respiratory Effort Monitoring for Obstructive Sleep Apnoea Diagnosis.Journal of clinical medicine · Jun 20, 2024
Acoustic Sensing as a Novel Wearable Approach for Cardiac Monitoring at the Wrist.Scientific reports · Dec 27, 2019
Clinical validation
NCT06836375 · Sponsor · NOT YET RECRUITING
Clinical Evaluation of a Paediatric Sleep Diagnosis TechnologyNCT04031950 · Sponsor · RECRUITING
Pulse Oximeter Accuracy During Stable Hypoxia PlateausNCT06460246 · Sponsor · COMPLETED
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep ApnoeaNCT04028011 · Sponsor · UNKNOWN
The Use of Wearable Technology to Acquire Signals for COPD ResearchNCT04495062 · Sponsor · COMPLETED
AcuPebble to Remotely Monitor Patients With OSA on CPAP TherapyNCT06097949 · Sponsor · UNKNOWN
Regulatory
No linked records are currently available.
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Sleep apnea detection vs ambulatory gold standard
Sleep apnea detection vs ambulatory gold standard
Patients able to complete test without training
Agreement with sleep specialist vs 12% for PSG software
Moderate and severe sleep apnea cases
Clinical trial comparing AcuPebble to Polysomnography software for sleep apnea detection
90% apnea detection agreement with sleep specialist vs. 12% for Polysomnography software (7x more accurate); 100% detection of moderate and severe sleep apnea cases
Selected as one of 12 innovations to be supported to scale across NHS England
Selected from competitive field for NHS-wide implementation support
Clinical validation trial comparing AcuPebble to at-home multi-channel polygraphy for sleep apnea detection
94% PPV, 98% NPV accuracy; 100% of patients able to complete test without training
05 · Leadership
Leadership profiles and professional links from the current Company record.
Esther Rodriguez-Villegas
Founder and Professor
06 · Company updates
Recent articles published on Acurable's official website.
07 · HAIC coverage
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Curated official destinations from the active Company record.
09 · Market pathway
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Market context
Companies providing AI-powered remote patient monitoring solutions, wearable health devices with AI analytics, continuous health tracking, or platforms that monitor patients outside clinical settings. Includes general wellness wearables with AI coaching, respiratory monitoring devices, and connected health platforms that aggregate and analyze physiological data from sensors.
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