OtoNexus Medical Technologies


Developer of an investigational AI-enabled ultrasound otoscope intended to provide objective, point-of-care assessment of middle-ear conditions. The program combines a miniaturized through-air ultrasound sensor embedded in a disposable speculum tip with automated signal acquisition and AI-assisted analysis, and is advancing clinical validation, regulatory planning (including FDA STeP participation), intellectual-property protection, and commercialization readiness for a capital-equipment plus recurring-consumable business model.

Industries

Health Care
Health Diagnostics
Medical
Medical Device
Medical Equipment Manufacturing

Nr. of Employees

small (1-50)

OtoNexus Medical Technologies

Bellevue, Washington, United States, North America


Patents

Infrared otoscope for characterization of effusion

US-12733814-B2

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Systems and methods for simulating a tympanic membrane

US-12614474-B2

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Methods and systems for CMUT resonance determination

US-12544044-B2

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Wearable auscultation device

US-12390184-B2

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Apparatus and method for characterization of acute otitis media

US-12167934-B2

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Apparatus and method for characterization of a ductile membrane, surface and sub-surface properties

US-12167936-B2

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Products

AI-enabled ultrasound otoscope (investigational)

An investigational point-of-care otoscope that combines through-air ultrasound sensing embedded in a disposable speculum tip with automated acquisition and AI-assisted analysis to provide objective information about middle-ear effusion during routine ear exams.

OtoNexus ultrasound otoscope

The first ear check device that provides crucial information about the presence and type of middle ear infection within seconds, enabling clinicians to quickly provide precise, accurate treatment of middle ear infections.


Services

Collaborative clinical research programs with clinical sites to evaluate the investigational ultrasound otoscope and generate performance evidence for regulatory submissions.

Activities to prepare device design, regulatory strategy, manufacturing readiness, and market partnerships for future product introduction.

Expertise Areas

  • Point-of-care diagnostic device development
  • Through-air ultrasound transducer R&D
  • AI/ML signal processing for medical diagnostics
  • Clinical study design and management
  • Show More (4)

Key Technologies

  • Through-air ultrasound sensing
  • Miniaturized ultrasound transducers
  • AI-driven signal analysis
  • Embedded sensor-in-speculum design
  • Show More (3)

News & Updates

Company selected for the FDA Safer Technologies Program to facilitate earlier and more frequent engagement with FDA during device development and review.

Admission into the Consortium for Technology & Innovation in Pediatrics (CTIP) accelerator to support pediatric device development and commercialization.

Received National Science Foundation SBIR Phase IIB grant to support ultrasound platform technology development.

Website pages describe through-air ultrasound technology, AI-assisted analysis, planned disposable tip model, and clinical/regulatory activities.

Recognized by Keiretsu networks as a Most Valued Company across multiple investor expos.

Industry recognition for work addressing antibiotic stewardship and infection-control objectives.

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