ACTING TODAY

FOR PATIENTS TOMORROW

We are taking action every day to bring our vision to reality. Our completed steps are summarized below.

Patent Granted:

We have received a favorable determination on our technology from the World Intellectual Property Organization administering the International Patent Cooperative Treaty, which grants us an international priority date for our system. Following this, we have applied for, and been granted, a United States Patent.

Prototype Completed:

After successfully demonstrating proof of concept, we have built a series of iterative prototypes that demonstrate feasibility of our design concept. Following these milestones, we have moved into the formal engineering process designed to meet ISO 1348 standards and future FDA submission requirements.

US Food and Drug Administration:

We have met with FDA representatives through the Q-submission process to review our concept and discuss implementation methods and regulatory pathways. We received constructive feedback, and have adapted our design to comply with the feedback we received.

Engineering:

We have chosen to partner with Starfish Medical (a leading Canadian device development firm) for formal engineering and product development, as well as regulatory support. Starfish has a strong record of bringing early stage medical devices through designe and regulatory pathways to market.
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