FDA grants 510(k) clearance for Alzheimer’s, dementia diagnosis software

Because of your extra risk of dementia from your stroke, does your hospital have enough functioning brain cells to get this software? 

Do you prefer your hospital incompetence NOT KNOWING OR NOT DOING anything on this?

Your risk of dementia, has your doctor told you of this?  Your doctor is responsible for preventing this!

1. A documented 33% dementia chance post-stroke from an Australian study?   May 2012.

2. Then this study came out and seems to have a range from 17-66%. December 2013.`    

3. A 20% chance in this research.   July 2013.

4. Dementia Risk Doubled in Patients Following Stroke September 2018 

The latest here:

FDA grants 510(k) clearance for Alzheimer’s, dementia diagnosis software

The FDA has granted 510(k) clearance to German medical technology company AIRAmed for its medical image management and processing system designed to assist physicians in early detection of Alzheimer’s disease and other dementias.

According to a company press release, the AIRAscore system utilizes deep learning and artificial intelligence technology to provide quantitative assessment of brain volume with objectively verifiable data using standard MRI brain scans. The process can be completed in just 5 minutes.

The FDA has granted 510(k) clearance to AIRAmed for its AIRAscore brain volumetry software, which can help clinicians diagnose and distinguish between different forms of dementia and other neurological conditions. Image: Adobe Stock

In addition to reporting absolute values with accurate volumes of tissues and brain areas, standardized to an individual’s anatomy, the system compares these volumes with a large reference population, corrected for head size, age and sex. The data is presented in an easy-to-understand format, comparable to a blood laboratory report, the release stated.

“For so long, we’ve been limited to reading a patient’s MRI to detect Alzheimer’s and other dementias,” Tobias Lindig, MD, AIRAmed’s founder and managing director, said in the release. “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. 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.”

The company further stated its technology aids in the differentiation of several dementia forms, including AD, frontotemporal dementia, movement disorders like atypical Parkinson syndromes and other conditions with known patterns of brain volume loss. Additionally, AIRAscore can provide auto segmentation of grey matter, white matter, cerebrospinal fluid and T1 hypointensities, along with detailed measurements of all brain lobes, midbrain and pons, hippocampus, cerebellum and ventricular systems.

The software, which has been used in Europe for 4 years, will be available for purchase in the United States in the first quarter of 2024, the release stated.