The September Edition of MIDI News & Updates

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Forest Devices Achieves Major Milestone: FDA 510(k) Clearance for SignalNED Model RE System

We are proud to announce that our client, Forest Devices, has achieved FDA 510(k) clearance for their SignalNED Model RE System. This marks an important step in their journey to revolutionize early stroke detection through EEG technology. The system’s rapidly deployed headset, the Sensor Cap, allows clinicians to acquire critical information about a patient’s brain state in just minutes, enabling timely and accurate neurological assessments.

This milestone is a testament to the incredible work and collaboration of Forest Devices’ talented team. At MIDI, we are honored to have partnered with them from the early stages of their journey, contributing to the design and development of this life-saving technology.

Our collaboration began in 2019, shortly after Forest Devices won the MedTech Innovator Global Competition. Over the years, we’ve worked closely to bring their innovative platform to life, and we couldn’t be prouder of this accomplishment.

Congratulations to Forest Devices on this remarkable achievement! We look forward to seeing the continued growth of the SignalNED platform and its impact on improving health outcomes for patients worldwide.

For more information about the SignalNED Model RE System and its impact click here.

Join Us at The MedTech Conference in Toronto!

We are excited to announce that we’ll be exhibiting at The MedTech Conference in Toronto, Canada, hosted by AdvaMed from October 15-17, 2024, at Booth 618. This will be a great opportunity to connect with industry professionals and showcase our expertise in medical device development.

In addition, our CEO, Christopher Montalbano, will be presenting at the Solutions Showcase on Wednesday, October 16, at 3:00 PM. His presentation, “Paradigm Perception Shift in Medical Device Development: The INNOVATION ROADMAP,” will dive into how regulatory design controls and risk management processes, often perceived as hurdles, can actually fuel innovation. This is a session you won’t want to miss if you’re looking to leverage FDA guidance for successful medical device commercialization.

We are also excited to be attending this event following the recent opening of our Toronto Division. We’re grateful for the support and guidance from Canadian Government Departments and several MedTech organizations in the Toronto area, which have helped make this expansion possible. A special thank you to our partners, including the Consulate General of Canada in New York, Invest Ontario, Life Sciences Ontario, and many others.

Let’s Connect!
Whether you’re attending the conference or not, we’d like to meet! If you’re in Toronto for the event, stop by Booth 618 or contact us to schedule a time. If you’re unable to attend in person, we’re happy to arrange a virtual meeting as well.

To schedule a meeting, click here.

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