FDA Approves AI-Incorporated Alzheimer Detection Software AIRAscore

Tobias Lindig, MD

According to an announcement, the FDA has granted 510(k) clearance to AIRAmed for AIRAscore, a deep learning and artificial intelligence (AI)-incorporated medical image management and processing tool designed to detect Alzheimer disease (AD) and other related dementias at the earliest point. AIRAscore, which has been commercially available in Europe for 4 years, will be available for purchase in the US in the first quarter of 2024.¹

With AIRAscore, clinicians are able to objectively assess MRI brain scans of patients in a quick manner and compare them with a large reference population, corrected for head size, age, and sex. The technology provides absolute values of volumes of tissues, including information on different lobes and limbic structures. Through this, clinicians can identify brain volumes that are not age appropriate, further aiding in the differentiation of other dementia forms and movement disorders.

"For so long, we’ve been limited to reading a patient’s MRI to detect Alzheimer’s and other dementias. However, we know from several studies that patients with these brain diseases suffer from subtle brain volume loss early in their disease course that cannot be observed with the human eye," Tobias Lindig, MD, founder and managing director, AIRAmed, and specialist in both radiology and neurology, University Hospital Tubingen, said in a statement.¹ "With AIRAscore, we are now offering physicians a highly precise, quantitative tool for the rapid detection of areas with a brain volume below the normal range."

According to the company, the software is quite affordable and can be configured by a hospital’s or radiology facility’s IT department in less than an hour. AIRAscore also offers auto segmentation of grey matter, white matter, cerebrospinal fluid, and T1 hyperintensities while providing detailed measurements of all brain lobes, midbrain and pons, hippocampus, cerebellum, and ventricular systems to support the diagnostic process.

Lindig added, “We believe our technology has the potential to be a game changer in the patient care journey, as brain volumes are of interest to physicians in the early disease course and also during the course of a disease to monitor the brain volume over time during therapy.”

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The technology offers several advantages, including both a standardized and objective neuroradiological view of the brain. By comparing patients to an age- and gender-specific reference collective, clinicians are able to detect atrophy at a stage where conventional visual examinations do not yet provide reliable findings. In addition, a deviation from the normal aging process can be detected during follow-up examinations even before the presence of atrophy that exceeds that age-appropriate level.

"The innovative brain volumetry system AIRAscore offers new possibilities in diagnosis and treatment of neurodegenerative diseases with an easily accessible surrogate parameter of disease activity," Ahmed Othman, neuroradiologist, University Hospital Mainz, Germany, said in a statement. "This is a big milestone for early detection, differential diagnostics and disease monitoring in dementias."

The FDA’s decision to clear AIRAscore comes at a critical time in which novel therapeutics for neurodegenerative diseases are starting to enter the treatment landscape. A lot of these agents, most notably, lecanemab (Leqembi; Eisai), are available for those with a confirmed diagnosis of mild cognitive impairment or mild AD that is supported by documentation of amyloid-ß in the brain.

REFERENCES
1. AIRAmed recieves FDA 510(k) clearance for its AIRAscore brain volumetry software. News release. September 19, 2023. Accessed September 19, 2023. https://www.businesswire.com/news/home/20230919787530/en/AIRAmed-Receives-FDA-510-k-Clearance-for-Its-AIRAscore-Brain-Volumetry-Software
2. AIRAscore structure. AIRAmed. https://arzt.airamed.de/en/airascore-structure. Accessed September 19, 2023.