FDA Approves Israel-Developed Delphi-MD, Creating New Category for Brain Assessment

Jerusalem, 19 November, 2025 (TPS-IL) — QuantalX Neuroscience, an Israeli-founded company, received FDA de novo clearance for its Delphi-MD system, a first-of-its-kind functional neuro-imaging device designed to rapidly assess brain function. The approval makes the technology available for clinical use in the United States, following earlier CE-MDR authorization in Europe.

CEO and co-founder Dr. Iftach Dolev said the device “gives clinicians an essential piece of the brain evaluation puzzle” by benchmarking patient responses against a proprietary database of healthy brains. The system combines non-invasive transcranial magnetic stimulation with EEG to deliver insights on neurological health in under an hour.

The technology is already being used in research at major U.S. hospitals, including Mass General-Brigham and Penn Medicine.