Deans' stroke musings: FDA grants 510(k) clearance for software to image the brain’s white matter

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Friday, August 11, 2023

FDA grants 510(k) clearance for software to image the brain’s white matter

This would be great for getting an objective damage diagnosis on white matter damage from your stroke, because right now your doctor has no clue what white matter damage there is and what protocols are needed for dendritic branching and axon pathfinding to fix white matter damage. This would allow factual proof that the protocols used fix white matter damage.

dendritic branching (38 posts to February 2012)
dendritic spine formation (6 posts to February 2017)
axon pathfinding (36 posts to March 2012)
axon regeneration (13 posts to June 2016)

FDA grants 510(k) clearance for software to image the brain’s white matter

The FDA has granted 510(k) clearance to a Canadian neuroimaging company for its quantitative imaging software, which assists neurologists and radiologists dealing with brain white matter issues for adjunctive care.

According to a press release from Imeka, the Advanced Neuro Diagnostic Imaging (ANDI) software extracts white matter bundles that connect specific regions of the brain and analyzes their microstructure. The artificial intelligence-assisted device processes diffusion-weighted images via modeling, tractography and fiber bundling to map microstructural properties of the white matter.

Generic FDA News infographic — Imeka received 510(k) clearance from the FDA for its brain white matter imaging software. Image: Adobe Stock

ANDI then generates a Digital Imaging Communications in Medicine (DICOM) report, which focuses on the bundles with the greatest deviation from the normative range, and offers a detailed analysis of all bundles’ microstructural and macrostructural values, the company said.

“We are pleased to announce FDA 510(k) clearance of ANDI, our quantitative imaging software, and make the technology available to health care providers across the U.S.,” Imeka CEO Jean-René Bélanger said in the release. “This also comes at a very crucial time with the announcement of the addition of two new CPT III codes by the AMA for quantitative brain MRI assessment, which we expect our clients to be able to get reimbursement from, starting in January 2024."