Activation of Second US Pivotal Trial Site, Mayo Clinic
| Stock | Emvision Medical Devices Ltd (EMV.ASX) |
|---|---|
| Release Time | 28 Apr 2025, 8:25 a.m. |
| Price Sensitive | Yes |
EMVision Activates Second US Pivotal Trial Site at Mayo Clinic
- Site initiation visit and device training at Mayo Clinic in Jacksonville, Florida scheduled for early May
- UTHealth and Memorial Hermann-Texas Medical Center site initiation visit and device training currently in process
- The Pivotal (validation) trial is designed to support FDA De Novo clearance of the emu™ Point-of-Care Brain Scanner device
EMVision Medical Devices Ltd has announced the activation of its second US pivotal (validation) trial site at Mayo Clinic in Jacksonville, Florida. The site initiation visit and device training at the Mayo Clinic site is scheduled to commence in early May. In addition, the site initiation visit and device training at the first US site, University of Texas Health Science Center at Houston (UTHealth) Medical School and Memorial Hermann-Texas Medical Center (TMC), is currently underway this week. Coinciding with the UTHealth and Memorial Hermann-Texas Medical Center site visit, EMVision has been invited to present at the inaugural Novel Treatments for Acute Brain Injury (NABI) conference held in Houston. This invite-only meeting of leaders in neurocritical care research is aimed at accelerating the transformation of the field. The Pivotal (validation) trial is designed to support FDA De Novo clearance of the emu™ Point-of-Care Brain Scanner device, with additional sites to be announced and activated shortly in both the US and Australia.
EMVision is focused on activating additional pivotal trial sites in the US and Australia to support the FDA De Novo clearance of its emu™ Point-of-Care Brain Scanner device.