Next step is a validation trial as the company seeks a de novo clearance from the FDA.
Australian medical imaging company EMVision will move forward with a validation trial of its portable brain scanning technology after positive results from a clinical study testing its Emu brain scanner for its ability to identify stroke and stroke type.
In total, 307 participants were enrolled in the EMView trial and successfully scanned with the EMVision Emu brain scanner across Liverpool Hospital, Royal Melbourne Hospital and the Princess Alexandra Hospital.
This included 277 suspected stroke patients with 48 haemorrhages and 140 ischemic confirmed strokes.
The study’s primary objective of collecting matched EMVision Emu brain scans and patient CT/MRI brain scans for the advancement of the scanner’s AI-based diagnostic “blood or not” and “clot or not” algorithms was achieved.
To train the AI algorithms, over 240 participants’ scan data was used (including confirmed haemorrhagic and ischaemic strokes, a variety of common stroke mimics and healthy volunteer scans).
This enabled the algorithm to learn patterns and features associated with a normal versus abnormal brain, including hyperacute, acute, subacute and chronic ischaemic and haemorrhagic stroke. The training set was diverse, with varied cases (across demographics, stroke sizes and locations, and time from onset) to enhance the model’s generalisability.
The neurodiagnostic AI algorithms were then applied to a test dataset that was isolated and not used in the training. This prevented the model from “learning” any patterns from the test data, ensuring the assessment provided a real-world evaluation with truly unseen cases, albeit on a smaller sample size, prior to definitive sensitivity/specificity confirmation in EMVision’s upcoming validation (pivotal) trial.
The results showed 92% sensitivity and 85% specificity in the “blood or not” arm, and 85% sensitivity and 78% specificity in the “clot or not” arm.
The results of the study will be submitted for publication following peer review.
The validation trial will attempt to demonstrate diagnostic performance of the portable brain scanner to support an FDA de novo clearance. EMVision is expecting to recruit up to 300 suspected stroke patients across a minimum of three US-based centres and two domestic stroke centres.
EMVision has site visits scheduled this month with its prospective US luminary investigational sites. The validation trial duration is estimated at between six and 12 months.
“The results are very encouraging, particularly as related to detection capabilities and sensitivity to small haemorrhages,” said Professor Geoffrey Donnan and Professor Stephen Davis, co-chairs of the Australian Stroke Alliance.
“We look forward to confirmation of this impressive neurodiagnostic capability in the validation trial.”
EMVision’s CEO, Scott Kirkland, said:
“There is a huge unmet need for stroke and stroke type diagnosis at the point-of-care.
“We can fill that need. We are very proud of these results which highlight our technology’s unique neurodiagnostic capabilities.
“We remain focused on progressing and executing our clinical validation and commercialisation strategy as we look to revolutionise stroke diagnosis and make a substantial positive impact on one of the major causes of global disability.”