FDA classifies an AI Parkinsonism diagnostic aid
On 3 April 2026 the U.S. Food and Drug Administration classified, through the De Novo pathway, neuropacs, a software device by Automated Imaging Diagnostics - the first device in a new generic type, 'Parkinsonian syndrome diagnostic aid' (Class II, product code SHO), which analyses diffusion MRI data to help distinguish Parkinson's Disease, Multiple System Atrophy Parkinsonian variant and Progressive Supranuclear Palsy.
Why it matters
The regulator created, for the first time, a distinct generic device type and product code specifically for software that analyses MRI to distinguish Parkinsonian syndromes, with no legally marketed predecessor - opening a simplified 510(k) path for later, similar devices. An editorial assessment.
The applicant is Automated Imaging Diagnostics, LLC; the De Novo request was filed under section 513(f)(2) of the Food, Drug and Cosmetic Act on 2 March 2026, since no legally marketed predicate device existed for comparison. Indications for use: neuropacs analyses diffusion MRI data from patients 40 and older with Parkinson's Disease (PD), Multiple System Atrophy Parkinsonian variant (MSAp) or Progressive Supranuclear Palsy (PSP) and produces a classification report to help neurologists and neuroradiologists distinguish MSAp and PSP from PD; it is not a stand-alone diagnostic tool and is meant for use only after clinicians have ruled out other causes of parkinsonism. The FDA set Class II special controls: clinical performance validation against a clinically relevant reference standard with objective performance measures, software verification and validation with a hazard analysis, and labelling requirements (a summary of test methods, the population used to develop the model, its limitations, and cautions on interpreting its output). The order lets the company market the device immediately under these conditions. What the record does not claim. The order does not publish the clinical test results themselves - it only requires them to be in the device's labelling - so this record gives no accuracy figures, because the document contains none. The 'Dated: December 4, 2024 / Received: December 4, 2024' line in the letter's administrative header is most likely an FDA template artefact: the letter's own text states the De Novo request itself was received on 2 March 2026, and that date, not December 2024, is the one consistent with the date of the order.