August 12, 2025 | Like a smartphone housing many software applications, a multi-purpose platform looks to be the launchpad for a potentially huge number of medical devices. The Openwater system, under development for nearly a decade, holds promise in noninvasively diagnosing and treating disease using infrared light and low-intensity focused ultrasound (LIFU), according to Aaron Timm, CEO of the San Francisco-based company.
Openwater has two breakthrough devices—Open-Motion, a blood-monitoring and diagnosis tool, and Open-LIFU, which delivers low-energy sound waves to treat disease—being used as the starting point for technology innovations spanning oncology, stroke care, mental health, and long COVID, he says. While building these devices itself, Openwater also provides tools and a framework for others to develop and commercialize medical technology more efficiently and affordably via open-source licensing.
Neither Open-Motion nor Open-LIFU have yet to be approved or cleared by the U.S. Food and Drug Administration (FDA), but they offer time- and cost-saving benefits to various stakeholder groups, says Timm. Investigators get access to shared safety data generated from the devices, accelerating the validation phase of their research. And since they’re not starting from scratch, it helps minimize the risk to investors and provides faster returns.
Regulators appreciate Openwater’s transparency with the safety data as well as the real-time data-sharing, Timm continues. This helps speed the approval process, which means patients have access to useful and affordable medical devices sooner.
The open-source platform also allows for parallel data collection from multiple trials and projects with shared safety data sets, he adds. That better addresses the FDA’s top concern—patient safety. The new administration also seems to be welcoming of non-traditional, non-pharmaceutical approaches to diagnosing and treating disease.
Costs are being driven down by leveraging both open-source development and consumer electronics manufacturing processes, Timm says. This will be particularly important for the “global middle class” beyond the United States.
Since the company’s launch in 2016, devices once occupying an entire room have been successively downsized to the size of a washer then to something that could be pushed in a shopping cart then to what exists today—a console connected to a headband, Timm elaborates. They rely on electronics and semiconductors as well as a whole lot of engineering know-how and innovation.
As of this year, the first of the latest portable, modular versions of the devices is being shipped out for use in basic research projects as well as clinical trials conducted with the newest generation of Open-LIFU, he says. The publicly-disclosed academic collaborators include researchers at the University of Arizona, the University of Pennsylvania, Brown University, the University of Birmingham, and Massachusetts Institute of Technology (MIT).
Openwater licenses its intellectual property under an Affero General Public License and its hardware under a Creative Commons license, which are standard in their respective domains, says Timm. This provides licensees access to the source code and blueprints to take them in any direction they choose, including modifying and extending the code and distributing copyrighted works.
The hardware component consists of a console, somewhat like an Xbox, and a wearable that can be strapped around the head or, alternatively, the arm, leg, or other body part. “There are no drugs involved, and no injections,” he says. The console and wearable are connected via a cord.
Former MIT professor Mary Lou Jepsen, Ph.D., founded Openwater after recognizing the need for innovation in the medical device space, says Timm. She has a background in consumer electronics and engineering and was a key figure in the One Laptop per Child project.
Jepsen was particularly alarmed at the inordinate amount of time it takes to get medical devices to market—roughly 13 years—which stood in stark contrast to her experiences with other types of technologies and seemed never to comply with Moore’s law. That is, they tend not to exhibit improvement in price and computing power every few years, due largely to the complexities of medical device development.
Her strategy for disrupting the logjam and advancing research was to start building open-source, “general purpose” devices with multi-purpose applications—a concept that in 2016 had not yet taken hold, he points out. Researchers have been embracing the opportunity over the past few years, applying Openwater’s hardware and software to different indications of interest.
In preclinical studies with mice, Open-LIFU has been shown to successfully break up glioblastoma tumors, delaying disease progression, reports Timm. It has also been used therapeutically to target and break up cancer cells and small tumors and to modulate brain activity as well as break up blood clots.
When an Open-LIFU-based application was tested on patients with treatment-resistant depression in a clinical trial, a significant proportion ended up going into remission (Frontiers in Psychiatry, DOI: /10.3389/fpsyt.2025.1451828). More recently, researchers have been testing the utility of low-intensity focused ultrasound in breaking up amyloid microclots thought to be linked to long COVID (Frontiers: Bioengineerng & Biotechnology, DOI: 10.3389/fbioe.2025.1604447)
Using infrared light, Open-Motion has most notably been used for diagnosing blood flow to the brain to objectively determine if there is a large vessel occlusion (LVO), which leads to acute ischemic stroke, he continues. “We have a great deal of precision and accuracy compared to traditional [diagnostic] methods,” based on observations of facial drooping or weakness, slurred speech, and loss of body control (Journal of NeuroInterventional Surgery, DOI: 10.1136/jnis-2024-021536).
More recently, the performance of the Open-Motion-based device was found to successfully identify patients in need of endovascular therapy when optimized for maximum sensitivity (Journal of Stroke & Cardiovascular Diseases, DOI: 10.1016/j.jstrokecerebrovasdis.2025.108323). At maximum specificity, the device could also effectively minimize false positives.
The application for LVO diagnosis is probably furthest along the development path, Timm says. Based on promising findings in the initial clinical trials, FDA approval of this medical device could be a reality in another couple of years.
Since Open-LIFU uses low-intensity focused ultrasound, it is an inherently safe device, Timm says. High-intensity focused ultrasound involves a greater degree of risk to users since it ablates tissue using heat while LIFU modulates or disrupts specific targets to potentially impact nerve activity or facilitate drug delivery.
Despite being very low risk, the technology of Openwater has been shown in several clinical trials to be highly effective, he reiterates. “Eventually, we fully expect that our devices will have FDA clearance or approval for specific applications.”
With further development, Open-LIFU and Open-Motion have many potential uses that will need to individually go through the regulatory review process, say Timm. “That is either something we can do, or our partners or researchers can do.”
The marketed products are likely to all be class II medical devices, a category the FDA reserves for “relatively low-risk types of devices,” he continues. Most medical devices, including powered wheelchairs and pregnancy test kits, fall into this category. The potential approval pathways include 510(k) premarket submission to demonstrate that the device is substantially equivalent to a legally marketed device and the de novo route for novel devices without a predicate device that typically requires clinical trials.
Building a ‘Silicon Hospital’
The expectation is that the Openwater approach will shave the time it takes to get useful medical devices to market while also lowering the cost of purchasing them, Timm says. “The only way we can do that is through scale of production and making many more of these devices.”
The goal is to lower the price point below $1,000 per unit over the next several years. “Given how rapidly we’ve driven down the cost of the device so far, we think that is achievable,” says Timm. Prices could plummet much as they did for large-screen televisions, in that case from several thousand dollars in the early 2000s to under $250 today—while delivering a better product.
The broad vision of Openwater is to use its platform in the creation of a “Silicon Hospital” describing a future state where hospital-grade medical care is rendered non-invasively and available everywhere on the planet, says Timm. It is intended to conjure up the fame of Silicon Valley, a global hub for technology and innovation that led to the creation of groundbreaking products and entirely new industries.
“The entire healthcare system has potential partners for us ... from the caregivers to the hospitals to the innovators who are building the different applications on our platform,” he says. “We’re going for a large ecosystem of players that all have a role ... in terms of the vision and how it all fits together, and I think it could really be transformational.”