Innolitics and BEACON-Neuro.AI Inc. have partnered to advance BEACONPredict, an artificial intelligence (AI)-based software designed to predict the risk of malignant cerebral oedema following acute ischaemic stroke.
The collaboration brings together Innolitics’ medical-device software engineering and FDA regulatory expertise with clinical research from the neurocritical-care laboratory of Dr Raj Dhar at WashU Medicine.
The partnership has helped progress BEACONPredict from a research prototype towards development as an FDA Breakthrough Device.
Malignant cerebral oedema is a potentially life-threatening complication of large ischaemic strokes.
Early identification of patients at increased risk may help clinicians intensify monitoring and consider timely interventions, including decompressive surgery where appropriate.
BEACONPredict analyses early brain-imaging changes alongside clinical information to generate a risk estimate for clinicians.
The software is being developed as a clinical decision-support tool and is pursuing the FDA De Novo pathway.
The technology received FDA Breakthrough Device Designation during its first review cycle and was also accepted into the FDA’s Total Product Life Cycle Advisory Programme (TAP) pilot.
The programme provides opportunities for enhanced interaction with the FDA during development.
BEACON-Neuro.AI plans to raise US$0.5 million in pre-seed funding followed by a US$2.7 million seed round to support FDA clearance and commercial development.
