# QuantalX's Neurodiagnostic Device Earns FDA Breakthrough Designation

**Published:** 2023-05-30
**Source:** https://www.startuphub.ai/ai-news/startup-news/2023/quantalxs-neurodiagnostic-device-earns-fda-breakthrough-designation

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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](https://www.prnewswire.com/news-releases/neurosense-and-quantalx-collaborate-to-improve-early-detection-and-treatment-of-neurodegenerative-diseases-301743129.html) 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](https://investors.nanox.vision/news-releases/news-release-details/nanoxarc-imaging-system-receives-fda-clearance-pioneering-new) 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.

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