EMVision Medical Devices (ASX:EMV) Secures US Ethics Approval for Pivotal Trial
Regulatory Approval
EMVision Medical Devices Limited (ASX:EMV) has received central IRB ethics approval for its pivotal multi-centre diagnostic performance trial of the EMVision emu™ brain scanner in the United States. The study has been designated non-significant risk (NSR) by the IRB, facilitating rapid start-up and accelerated enrolment procedures.
Trial Progress
Site contracts and administration are currently being finalised, after which US investigational sites will be named. Australian ethics approval is in process, pending a near-term committee meeting. The pivotal validation trial, designed to support FDA De Novo clearance, remains on track for activation in March 2025.
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has positions in and has recommended EMVision Medical Devices. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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