- EmVision Medical Devices (EMV) has taken another step in its Breakthrough Device Designation (BDD) application
- The company receives feedback on its BDD application from the FDA, which suggested that although preliminary evidence supports the technology’s potential to differentiate and localise haemorrhagic and ischemic stroke, additional clinical data is required
- As a result of this, the BDD has not yet been granted to Emvision, but the company says it will continue to pursue it once clinical data is available
- EmVision Medical Devices is trading 3.91 per cent down at $2.95 at 10:47 am AEDT
EmVision Medical Devices (EMV) has taken another step it its Breakthrough Device Designation (BDD) application.
The company received feedback on its BDD application from the Food and Drug Administration (FDA), which suggested preliminary evidence supports the potential of the technology to differentiate and localise haemorrhagic and ischemic stroke.
However, the FDA responded that additional clinical study data is required, which EmVision will need to generate through further clinical development. As a result of this, the BDD has not yet been granted.
EMVision CEO, Ron Weinberger said the company was grateful for the feedback received from the FDA.
“Our pathway to FDA marketing authorisation remains unchanged, as does our preparation for expanded clinical studies and future commercialisation,” Dr Weinberger said.
The US Food and Drug Administration (FDA) BDD is a discretionary program that offers priority review and interactive communication across the device development and validation path. EmVision said it would continue to further pursue the BDD once the required clinical data is available.
Meanwhile, EMVision’s pursuit of the FDA De Novo regulatory marketing authorisation pathway for its first generation portable brain scanner product remains unaffected.
The company also said it expected to complete enrolment of the additional 20 patient datasets of its pilot trial this month, with processing and reporting of these additional datasets anticipated this quarter.
EmVision Medical Devices was trading 3.91 per cent down at $2.95 at 10:47 am AEDT.