- Mental health specialist Medibio (MEB) has applied for Breakthrough Device Designation with the U.S. Food and Drug Administration (FDA) for its MEB-001 tech
- Breakthrough Device Designation is designed to speed up the development, assessment, and review process of certain medical devices
- Essentially, this means if approved, Medibio will be able to fast-track its MEB-001 tech to market through ongoing discussion with the FDA
- MEB-001 is designed to diagnose and treat mental health issues objectively by analysing physiological signals
- The company will find out if its Breakthrough Device application is approved within 60 days
- Shares in Medibio are trading just over nine per cent lower this morning, currently worth one cent each
Medibio (MEB) has applied for Breakthrough Device Designation with the U.S. Food and Drug Administration (FDA) for its MEB-001 tech.
Essentially, the Breakthrough Devices Program is designed to speed up the development, assessment, and review process of certain medical devices.
There are strict criteria for a product landing Breakthrough Device Designation. For example, the product needs to provide more effective treatment than conventional devices or drugs, represent a breakthrough technology, and be better than approved alternatives just to be considered for designation.
If approved, however, it means Medibio will have more opportunities to talk to FDA experts about the device throughout the premarket review phase to make sure the device makes it to market as quickly as possible.
Medibio’s tech is designed to look at mental health issues objectively.
As the company explains, most depression screening tests are conducted through subjective self-report questionnaires, meaning they’re often biased and difficult to interpret.
The company’s MEB-001 tech, however, analyses physiological signals to review the mental health concerns objectively. The software-only tech can examine electroencephalogram (EEG) and electrocardiogram (ECG) signals taken from polysomnography (PSG). It can also automatically score sleep-study results.
Importantly, Medibio said there is no other FDA-approved alternative to this tech in the United States.
“Depression is one of the most common mental health conditions in the general population,” Medibio Chief Medical Officer Dr Archie Defillo said.
“Fifty three per cent of adults in the United States have reported that their mental health has been impacted by the COVID-19 pandemic,” he added.
“Thee need for an objective mental health tool has never been greater.”
The company said it should find out if its application for Breakthrough Device Designation is approved within 60 days
Shares in Medibio are trading 9.09 per cent lower in early action, currently, worth one cent each at 10:58 am AEST.