What's Happening?
QuantalX Neuroscience, an Israeli startup, has received FDA De Novo authorization for its Delphi-MD system, a first-of-its-kind functional neuro-imaging device. The system uses Transcranial Magnetic Stimulation
combined with electroencephalography to create a real-time functional map of brain activity. This non-invasive method provides clinically actionable insights for monitoring disease progression and evaluating treatment effects. The FDA clearance allows for commercial use in the U.S. and establishes a new regulatory category for brain function assessment tools.
Why It's Important?
The FDA clearance of Delphi-MD marks a significant advancement in brain health diagnostics, offering a novel approach to assessing brain function. This system could revolutionize neurological care by providing precise, real-time information about brain health, aiding in the diagnosis and treatment of conditions like stroke and dementia. The technology's ability to operate without specialized infrastructure makes it accessible to various healthcare settings, potentially improving patient care and outcomes across the U.S.
