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Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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

The Directory / Neurology & Neurotech

Omniscient Neurotechnology

Sydney, Australia · Series B · 510(k) cleared

Builds Quicktome, software that turns MRI and resting state functional MRI into patient specific maps of brain networks for surgical planning and deep brain stimulation.

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Omniscient Neurotechnology

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