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For intracranial bleeding, dabigatran had the lowest risk, followed by edoxaban, apixaban, rivaroxaban, and vitamin K antagonists

Assuming any necessary clinical data is already available and does not need to be gathered, many companies find that compiling a premarket application (PMA) for a high-risk device often takes 12-24 months, a de novo is 9-12 months, and a 510(k) is 4-6 months

doi: 10.1007/s11259-007-0050-3, 110

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In these rare cases, sterile saline is used

Neurochem Res Zhang Y, Zhao J, Afzal O et al (2021) Neuroprotective role of chrysin-loaded poly(lactic-co-glycolic acid) nanoparticle against kindling-induced epilepsy through Nrf2/ARE/HO-1 pathway [J]