Manufacturing News

EMVision plans to seek approvals for its stroke scanner

Manufacturing News

Imaging company EMVision Medical Devices is preparing for a meeting with the US Food and Drug Administration as it edges closer to seeking approval to market its emu point of care scanner to detect stroke.

The company has been developing a system that uses microwaves and AI in a machine small enough to fit in an ambulance to detect stroke, under a contract with the Australian Stroke Alliance.

The company said it was preparing for a pre-submission meeting with the FDA following analysis of its Stage 2 clinical trial results which involved a total of 180 patients presenting to emergency departments with stroke like symptoms.

Data from Stage 2 is being used to enhance AI algorithms in preparation for an upcoming validation (sensitivity/specificity confirmation) trial phase of its scanner.

EMVision CEO and Managing Director Scott Kirkland said: “The performance of our AI models thus far to help answer the big question ‘blood or not’ in acute stroke care is particularly encouraging.

“We will be using what we have achieved to help inform our upcoming consultation with the FDA.”

‘Blood or not’ equates to detection of haemorrhage and nonhaemorrhage in a patient.

EMVision said the data confirms strong AI model performance in answering this important clinical question in suspected acute stroke ‘blood or not’.

EMVision’s AI model is in a continuous development and integration phase and will continue to progress with data obtained in planned Stage 3 of the pre-validation trials, for which EMVision is currently recruiting patients.

Patients undergoing the trials are at three trial sites – Liverpool Hospital, Royal Melbourne and Princess Alexandra Hospital Brisbane.

Stroke Neurologist and Principal Investigator Dr Michael Devlin said: “The stroke team at Princess Alexandra Hospital have found the emu scanner easy to operate in a very busy and time-pressured environment when treating people with acute stroke.

“We have needed to adopt only minor workflow changes to ensure no impact on the other aspects of care in the emergency department.”

Further reading:
EMVision further develops its portable stroke scanner

Picture: EMVision Medical Devices

Share this Story
Manufacturing News

Stay Informed

Go to Top