FDA

FDA clears Omniscient's Quicktome Deep Brain for mapping brain networks in deep brain stimulation planning Company claim

• Omniscient announced on 11 September at 14:42 ET that Quicktome Deep Brain (DB) has received 510(k) clearance from the FDA, its third clearance.
• The company says the workflow localises leads, segments deep brain structures and maps white matter tracts within brain networks, for deep brain stimulation used in Parkinson's disease, essential tremor, dystonia and other movement disorders.
• The release states roughly 10,000 new DBS procedures are performed in the US each year — the scale against which any benefit would be measured.
• CEO Stephen Scheeler is quoted: "This is our third FDA clearance, and each one advances the same strategy: build the connectomic platform that becomes the standard across neuroscience care." A 510(k) clearance establishes substantial equivalence to a predicate device, not clinical benefit; the release reports no outcome data.