Neurophet Achieves FDA Clearance for Advanced Alzheimer's Imaging Solution

Neurophet Achieves Major Regulatory Milestone

On February 6, 2026, Neurophet, a pioneering company in AI solutions for diagnosing brain disorders, proudly announced that its software, Neurophet AQUA AD Plus, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This significant milestone solidifies Neurophet's innovative position within the neurological healthcare landscape, marking its third FDA approval following the prior clearances for Neurophet AQUA and Neurophet SCALE PET.

The authorized software plays a crucial role in the clinical assessment of patients suffering from Alzheimer's disease. It integrates advanced neuroimaging analysis, which is instrumental for clinicians navigating the complexities of neurodegeneration. By executing quantitative analyses on MRI and PET images, Neurophet AQUA AD Plus brings precision to clinical evaluations. This encompasses the automated labeling, visualization, and volumetric assessment of critical brain structures and lesions, alongside standardized uptake value ratio (SUVR) analyses.

With its cutting-edge capabilities, the software reveals vital insights by assessing neuroimaging features linked to cerebral microbleeds and brain edema. Consequently, it aids healthcare providers in making informed, patient-specific decisions during therapeutic management for Alzheimer's disease.

Enhancing Alzheimer's Care

As highlighted by Jake Junkil Been, Co-CEO of Neurophet, this FDA clearance allows for a broader introduction of advanced imaging technology in the U.S. market. The upgraded version of Neurophet AQUA AD aims to capitalize on its predecessor's capabilities, significantly enhancing its performance. By leveraging AI-driven brain MRI analysis, the software efficiently identifies and quantifies lesions related to cerebral microbleeds and edema, streamlining the decision-making process for clinicians.

Previously recognized as an Innovative Medical Technology in South Korea as of September 2025, Neurophet is now set to elevate clinical adoption of its innovative solutions on a global scale. The company aims to expand its reach by building strong collaborations with healthcare institutions and strategic partners throughout the U.S.

Moreover, Neurophet continues its dedication to aiding patients struggling with brain disorders. With a firm commitment to neuroscience advancements, the company envisions growth through developing groundbreaking solutions designed to tackle brain diseases utilizing artificial intelligence.

A Vision for the Future

Founded in 2016, Neurophet specializes in crafting tools for diagnostic support and treatment planning to combat brain disorders. Its cornerstone products include not only Neurophet AQUA AD but also Neurophet AQUA, urban imaging treatment planning software, and a suite of other advanced systems for various neurological applications.

As Neurophet progresses, the company stands at the forefront of innovation in neuroimaging, continually working to reshape how healthcare providers approach the diagnosis and treatment of Alzheimer's disease. By harnessing the power of artificial intelligence, Neurophet is taking instrumental steps toward revolutionizing the management of brain health, making great strides toward improved outcomes for patients across the globe.