QuantalX's neurodiagnostic device, Delphi-MD, received FDA breakthrough designation for diagnosing Normal Pressure Hydrocephalus (NPH) and predicting treatment response. This is the second time the device has received this status.
NPH is often under-diagnosed due to the invasive nature of the current diagnostic procedure. Delphi-MD aims to simplify this process by providing accessible neurodiagnostic capabilities at any point of care.
The FDA granted the breakthrough designation based on preliminary clinical data showing Delphi-MD's effectiveness in diagnosing NPH and predicting the success of shunt treatment.
The FDA's breakthrough designation was granted based on preliminary clinical data demonstrating Delphi-MD's superiority over the current standard-of-care diagnostic procedure in accurately diagnosing NPH and predicting the effectiveness of shunt treatment.
The company recently announced a collaboration with NeuroSense Therapeutics to improve early diagnosis and treatment of neurodegenerative diseases, like Alzheimer's Disease.
Israeli public company Nano-X Imaging recently received FDA clearance as well for its Nanox, ARC X-ray system, sending the stock up 187% since the announcement earlier this month. The system, which offers 3D visualization from a series of stacked 2D slices, aims to provide better information for radiologists by reducing the effect of overlaying structures.
