The field of medical technology has witnessed remarkable advancements in recent years, with groundbreaking innovations reshaping the landscape of diagnostics and therapeutic interventions. This repository is dedicated to providing transparent insight into the regulatory strategy, discussions, and pathway that Openwater has pursued to date with the United States Food and Drug Administration (FDA) for the Openwater LVO Stroke Alert, the Openwater Blood flow Headset, and Openwater Low Intensity Focused (LOFU) Ultrasound Therapy System. Among these transformative technologies, Openwater has developed the Openwater LVO Stroke Alert. The Openwater LVO Stroke Alert is intended for use as an early notification system to identify and communicate blood flow data on patients with suspected Large Vessel Occlusion of the internal carotid artery or the proximal middle cerebral artery. The proposed device is indicated for use in pre-hospital settings to allow medical personnel to make better routing decisions for patients suspected of anterior LVO. This technology along with the Openwater Blood Flow Headset have the potential to provide valuable blood flow data to medical professionals. Low intensity focused ultrasound represents another cutting-edge technology that harnesses the power of ultrasound waves at lower energy levels for therapeutic purposes. This technique has shown promise in diverse medical fields, such as targeted drug delivery, tissue regeneration, and neuromodulation. The Openwater Low Intensity Focused (LOFU) Ultrasound Therapy System is intended for safe neurostimulation of the prefrontal cortex. As we navigate the intricacies of optical blood flow and low intensity focused ultrasound technologies, this page serves as a valuable resource for professionals, researchers, and enthusiasts seeking a comprehensive understanding of the FDA's regulatory oversight in this dynamic intersection of medical science and technology.
Safety Disclosure This notification serves as a safety disclosure for the [Device Name], a medical device intended exclusively for research purposes. The [Manufacturer Name] acknowledges that, as of [Date], 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 devices 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 devices 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 devices 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 devices 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 devices 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.
This repository contails Openwater's files of information submitted to and communication with the FDA. We have three categories of filings - LVO Stroke, bloodflow and ultrasound. Please see our regulatory wiki page for more details. Our company wiki page is a good place to start if you are looking for an overview of our products.
