Open-Motion

Realtime Hemodynamics

Open-Motion

The Open-Motion hemodynamic platform usies low intensity near-infrared light to measure blood flow, blood volume, and micro-motions deep under the tissue surface.  Ready to use out of the box, and also as an open source architecture that allows for customization to suit a wide range of research needs. Standardized design features ensure that clinical studies conducted with these tools can generate critical data to inform the development of future portable, low-cost medical devices.

Key Features

A diagnostic platform designed for noninvasive measurement of blood flow, blood volume, micro-motions, and oxygenation deep beneath tissue surfaces.

  • Wearable, modular design for a wide range of applications
  • Microsecond laser pulses with high sensitivity and minimal exposure
  • Integrated machine learning for real-time classification and analysis
  • Compliance with IEC 60601-1; ISO 13485 certification in process
  • Complete platform or OEM hardware/software components
  • Research use only; pre-FDA

In a trial study designed to evaluate the ability of Open-Motion to detect Large Vessel Occlusion (LVO) in patients with suspected stroke, the Open-Motion outperformed both RACE and LAMS for the detection of LVO in patients presenting for acute stroke evaluation. A clinically relevant increase in sensitivity was observed for the Openwater blood flow monitor without a cost to specificity, which ultimately yielded fewer false negatives and false positives.

Favilla CG, Baird GL, Grama K, Konecky S, Carter S, Smith W, Gitlevich R, Lebron-Cruz A, Yodh AG, McTaggart RA. Portable cerebral blood flow monitor to detect large vessel occlusion in patients with suspected stroke. J NeuroIntervent Surg. Epub ahead of print: 21 March 2024. doi:10.1136/jnis-2024-021536

 

LVO Stroke

Specifications

  • Open-Motion 3.0 is a diagnostic platform using low intensity near-infrared light to measure blood flow, blood volume, and micro-motions deep under the tissue surface.
  • Flexible, easy-to-use, and can interrogate many locations throughout the head and body.
  • Open-source design allows customization and modification for clinical research across diverse users and applications.
  • Controlled design features make it an effective solution for developing regulated medical devices that are portable and low-cost.

Specifications

  • Light source: 795 ± 5 nm, 5 Watts, < 15 MHz, 250 µs, Class 1 emissions per IEC 60825
  • Detectors: CMOS, 16, Global, 1920 x 1280, 2.2 µm, 40 fps
  • Sample rate: 45Hz
  • Terminals and I/O signals: Electrical, optical, DC power supply, laser TTL sync
  • Mechanics: W: 250 mm, H: 75 mm, D: 160 mm, Approx. 2.5 kg
  • Software requirements: Windows 10, version 22H2 or later or Apple macOS 12 or later, 8 GB of RAM, 100 GB of free storage, 1 available USB-C port (at least USB 3.0)
  • Others: AC 100 - 240V, 50/60 Hz, 72 Watts (Maximum), 15°C - 30°C, 20% RH - 80% RH, -0°C - 40°C, 20% RH - 80% RH
  • Compliance: IEC standards 60601-1, 60825-1, 62304, ISO standards 13485, 10993

Intended Use Statement

  • Open-Motion 3.0 is intended to help qualified researchers study the use of optical blood flow and blood volume monitoring in laboratory, pre-clinical, and clinical research settings.
  • The system is designed to be flexible and re-programmable so that a wide variety of tissue types can be explored, while also enabling researchers to configure constrained operation modes for use by trained operators and entities seeking regulatory approval for specific indications.
  • Open-Motion 3.0 has not been evaluated by the FDA and is intended for research use only.