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Want a Early Access System?

You can have one!  We are now taking order reservations for

  • Open-Motion 3.0 - our Blood Flow unit module

  • Open-LIFU 2.0 - our Therapeutic Ultrasound unit module

These systems are targeted at ~$10k a piece in small volumes anticipated for this pre-regulatory approval R&D only build.  Exact pricing to be determined by the order volume for this build. This is a fully refundable place in line for the build.  In volumes that can come with regulatory approvals  the prices should reach ~$1k per unit and in high volume manufacturing can see sub $100 pricing. See product briefs below.

Now accepting Ethereum and Bitcoin.  Please reach out in the interim directly to community@openwater.health to order with cryptocurrency and we will handle it until we can automate it here.  

A modular Low Intensity Focused Ultrasound platform

 

Open-LIFU 2.0 is Openwater’s platform for multi-user, multi-application, low intensity focused ultrasound therapy. The modular design can be configured into proof-of-concept prototypes to support clinical research across a gamut of users and applications. By allowing individual users to configure their own systems, they can select and configure components optimized for their specific applications and develop medical devices that are efficient, low-cost, and portable.
 

Note: this is not FDA approved and is a Research Unit only

Open-LIFU 2.0 - Order Reservation

$100.00Price
  • This is a fully refundable place in line for the build.

  • This notification serves as a safety disclosure for our Open-LIFU and Open-Motion medical components intended exclusively for research purposes. Openwater acknowledges that, as of January, 2024 the device has not undergone review and clearance or approval by the U.S. Food and Drug Administration (FDA) for commercial distribution and use.

    Important Safety Information:

    Research-Only Purpose: The devices discussed on this site are exclusively intended for research purposes and are not cleared or approved by the FDA for clinical use or commercial distribution. It is solely available to researchers and research institutions.

    Lack of FDA Review: The safety and effectiveness of these components have not been established through the FDA's formal review process. Researchers should be aware that the device has not undergone the regulatory scrutiny required for general medical use.

    Risk Awareness: The potential risks associated with these componentss are not fully known. Researchers and research institutions are advised to exercise caution and fully inform all involved parties about the investigational nature of the device and the uncertainties surrounding its safety and efficacy.

    Informed Consent: Researchers using these components are responsible for obtaining informed consent from participants, clearly communicating the experimental nature of the device and any potential risks associated with its use.

    Monitoring and Reporting: Researchers are urged to closely monitor the use of these components during research activities and promptly report any adverse events or unexpected side effects to Openwater safety@openwater.cc. This information is crucial for ongoing evaluation and refinement of these devices.

    Restricted Use: These components should be confined to research settings and not used in clinical practice or commercial applications. Their use should be limited to researchers and research institutions with the expertise to manage and monitor the investigational nature of the device. For inquiries or additional information, please contact safety@openwater.cc

Further Discussion

We are documenting our improvements to this generation of Open-Motion and Open-LIFU on our  wiki and in github.  We now need make and build our next generation with some major improvements:

  • Large reduction in size and cost of our laser

    • we have been making samples of a pulsed diode laser with holographic-level high coherence in the infrared for years now.  We are ready to manufacture a run of these lasers for Open-Motion 3.0

  • Large reduction in size and cost of LIFU driving electronics

    • Ultrasonic array driving systems run hundreds of thousands of dollars.  We have invented, designed and built and tested prototypes which we have been refining for years now.  We are ready to do a large build for Open-LIFU 2.0

  • Large reduction in size and cost of our ultrasonic arrays. 

    • ​​Ultimately we want this in a PMUT/CMUT semi-chip but along the way we have found some low-cost high bandwidth piezo solutions for LIFU that are well matched to the rest of our system and the parameter space we have keyed in on based on our clinical results in cancer therapies and mental disease therapies  We are ready to do a next build and include this in Open-LIFU 2.0

  • System level reductions from these changes & Bulk ordering

Details above. 

Note these are not FDA approved yet and are available for R&D efforts only. 

 

Contact Us

In addition we have a small number of currently generation units available now.  Contact us at community@openwater.health for more info on their availability

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