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Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA only partly recognizes the 2025 biocompatibility standard and skips clause 6.9 ARPA-H commits $62.7M to autonomous heart failure AI and wants FDA packages in two years Stryker puts the March cyberattack at about $45M of Q3 sales Glucotrack raises $11.5M in convertible notes at a 22 percent original issue discount Cardiovascular AI notification software gets its own Class II regulation and a 510(k) path CMS covers TAVR for asymptomatic patients and drops the evidence requirement for symptomatic ones Nvidia takes its first equity stake in Verily Bausch + Lomb wins a CE mark for the SeeLyra femtosecond laser Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA only partly recognizes the 2025 biocompatibility standard and skips clause 6.9 ARPA-H commits $62.7M to autonomous heart failure AI and wants FDA packages in two years Stryker puts the March cyberattack at about $45M of Q3 sales Glucotrack raises $11.5M in convertible notes at a 22 percent original issue discount Cardiovascular AI notification software gets its own Class II regulation and a 510(k) path CMS covers TAVR for asymptomatic patients and drops the evidence requirement for symptomatic ones Nvidia takes its first equity stake in Verily Bausch + Lomb wins a CE mark for the SeeLyra femtosecond laser

510(k)

Omniscient clears a third Quicktome workflow, this one for deep brain stimulation

MedDevice Startups Staff · 3 days ago · 2 min read · Via Omniscient release

FDA cleared Omniscient Neurotechnology's Quicktome Deep Brain workflow on September 11. The software localizes deep brain stimulation leads and segments the deep brain structures around them. It also maps the white matter tracts connecting those regions, from planning through programming. It supports Abbott DBS hardware and covers Parkinson's disease, essential tremor and dystonia.

This is the third clearance for the Sydney company's Quicktome platform. The structural connectome and functional connectome workflows came first, both built for neurosurgical planning. Omniscient puts the US market at about 10,000 new DBS procedures a year. It raised an AUD 40M Series B in 2021 and later took a $20M investment from Australia's National Reconstruction Fund Corporation.

Stacking workflows on one cleared platform is the cheaper regulatory route. Each new submission reuses the same software documentation and the same predicate family. The third one costs far less to assemble than the first.

Questions & Answers

What did Omniscient Neurotechnology get FDA clearance for in September 2026?

Omniscient Neurotechnology received 510(k) clearance on September 11, 2026 for the Quicktome Deep Brain workflow. The software localizes deep brain stimulation leads, segments deep brain structures and maps the white matter tracts that connect them.

How many FDA clearances does Omniscient Neurotechnology's Quicktome platform have?

Three. The Quicktome Deep Brain workflow cleared on September 11, 2026, joining earlier clearances for the Quicktome structural connectome and functional connectome workflows.

How big is the US deep brain stimulation market Omniscient Neurotechnology is targeting?

Omniscient Neurotechnology cites roughly 10,000 new deep brain stimulation procedures a year in the United States, covering Parkinson's disease, essential tremor and dystonia.

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