Innolitics and BEACON-Neuro.AI Partner to Bring FDA Breakthrough Device BEACONPredict to Market
BEACONPredict, a tool that predicts dangerous brain swelling after a stroke, went from research prototype to FDA Breakthrough Device on the first review cycle. The partnership paired Innolitics' regulatory and software work with BEACON-Neuro.AI's neurocritical-care and imaging-focused research, and a De Novo pathway to market is now underway.
Innolitics, a medical-device software and FDA regulatory services provider, and BEACON-Neuro.AI Inc., a Washington University in St. Louis startup, today announced the partnership behind BEACONPredict, AI software for predicting malignant cerebral edema risk after acute ischemic stroke. Innolitics brought the regulatory strategy and software engineering; BEACON-Neuro.AI brought the clinical science out of Dr. Raj Dhar's neurocritical-care lab at WashU Medicine. Together the two companies took BEACONPredict from a research prototype to an FDA Breakthrough Device.
Malignant cerebral edema is a life-threatening complication after a large ischemic stroke, and catching it early is one of the harder calls in neurocritical care. A team that sees it coming can escalate monitoring or move to life-saving decompressive surgery before irreversible deterioration. BEACONPredict reads early brain-imaging changes alongside clinical variables and returns a risk estimate that supports the clinician's decision-making.
