Medical device regulatory consultancy
Appears in 2 stories · Last updated Oct 30, 2026
Prepared and managed NeuroDR's FDA submission
A stroke patient's head CT used to wait on a technologist stripping away bone, soft tissue and veins by hand before the arteries underneath could be read. NeuroDR, cleared by the FDA on October 7, does that step automatically and sends 3D views of the neck and brain arteries to the hospital's image archive.
Updated Oct 30
As of September 2026: Regulatory partner for Heartvue.Proton clearance
Reading a cardiac MRI by hand can take an hour. The FDA just cleared software that automates most of that work, and it comes with permission to keep improving itself.
Updated Sep 5
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