SmartAlpha’s Nerveblox™ receives FDA 510(k) clearance. Learn more
We are committed to leveraging AI to support clinicians realize the benefits of ultrasound imaging.
We are an interdisciplinary team united in our purpose to support clinicians with anatomy-aware intelligent ultrasound solutions to help unlock the power of ultrasound in a wide-range of clinical settings.
Our unique approach combines the expertise of clinicians and engineers, creating anatomy-aware intelligent ultrasound solutions, pushing the boundaries of state-of-the-art ultrasound practices, and setting new standards in ultrasound diagnostics.
Our Values
In addition to dedication to safety, health, and environmental protection requirements of medical device regulations and continuous conformity to ISO 13485 and ISO 62304 standards, we took an oath that we will always be aligned with these set of ethical principles:
Good Machine Learning Practice (GMLP)
The principles identified jointly by The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), guides us for safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
Good Clinical Practice (GCP)
GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. We strictly follow the associated standards to provide the highest-level ethically credible products.
Declaration of Helsinki
Ethical Principles for Medical Research Involving Human Subjects developed by WMA (World Medical Association), first released in Helsinki, is a statement of ethical principles which guides us on validating our technology through clinical studies involving human subjects, including research on identifiable human material and data.
