Imaginostics accelerates momentum with a new data layer for MRI

Imaginostics, a health technology company advancing MRI through quantitative vascular imaging and AI-powered analytics, is finalizing its Pre-IND briefing package for submission to the U.S. Food and Drug Administration, marking the latest in a series of milestones across product development, regulatory progress, and strategic partnerships. The company was recently nominated for the Clinical Excellence & Evidence Award by MedTech World, underscoring the promise of its platform technology to help shape the future of healthcare through more precise clinical care.

At the core of the company’s platform is a bold mission: to transform MRI from qualitative black-and-white images into measurable biology and actionable clinical insight. By creating a new data layer for MRI, Imaginostics aims to help physicians detect disease earlier, monitor it more precisely, and support more personalized care across neurology, cardiovascular disease, oncology, and other areas where vascular health plays a defining role.

Imaginostics’ platform is built around two complementary products: ImagiView™ and ImagiSight™.

ImagiView™ is the company’s quantitative vascular imaging platform, designed to visualize and measure vascular structure and function with greater precision than conventional MRI. ImagiSight™ is its AI-powered vascular intelligence platform, designed to transform imaging-derived data into advanced analytics and predictive insight. Working from ImagiView™ data, ImagiSight™ is being developed to extract quantitative vascular biomarkers spanning vascular structure, function, and leakage, including cerebral blood volume mapping, blood-brain barrier permeability, and small-vessel density.

Together, these platforms are intended to move medical imaging beyond subjective interpretation and toward a future where imaging can support earlier diagnosis, longitudinal monitoring, treatment planning, and true precision medicine with quantitative information at the individual level in a single MRI scan.

This momentum is being reinforced by a series of meaningful milestones. Imaginostics received FDA Breakthrough Device Designation, an important validation of the clinical potential of its technology. The company has also received a Letter of Support from Siemens Healthineers, reflecting growing strategic interest in its platform and approach, and continues to advance its regulatory and commercialization strategy while engaging with leading stakeholders across healthcare, imaging, and innovation.

“Our vision is to build a future where MRI does not simply show anatomy, but reveals measurable vascular biology that can guide better decisions throughout a patient’s life,” said Dr. Codi and Valerie Gharagouzloo, Cofounders of Imaginostics. “We believe imaging should play a much greater role in prevention, early detection, and personalized care, and we are building the tools to help make that possible.”

With its combination of deep scientific innovation, AI-powered data analytics, and a long-term commitment to improving vascular health, Imaginostics is positioning itself at the intersection of MedTech, digital health, and precision medicine.

As the company continues to grow, its mission remains clear: to make the invisible visible beyond black-and-white images, deliver more meaningful clinical insight from MRI, and support vascular health for life™.

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