The EvoWalk 1.0 System, designed to improve walking through AI-based functional electrical stimulation, now has FDA clearance.
OAKLAND, CA / ACCESSWIRE / January 22, 2024 / Evolution Devices, Inc. is thrilled to announce that the EvoWalk 1.0 System has been granted FDA 510(k) clearance. The clearance allows commercial sale of the device in the United States. EvoWalk is a non-invasive, wearable functional electrical stimulation (FES) device intended to provide ankle dorsiflexion and/or assist knee flexion or extension in adults with foot drop or muscle weakness related to upper motor neuron diseases or injuries (e.g.; stroke, multiple sclerosis, damage to pathways in the spinal cord).
EvoWalk uses novel, patented algorithms to understand a person’s leg movements and electrically stimulate muscles in the affected leg, to help partially paralyzed patients walk. Improved walking should help these patients regain their independence. The EvoWalk device is controlled via an app that patients and clinicians use to set up the device. Clinicians can remotely track their patients’ progress to personalize their care plan.
Highlights of EvoWalk’s Innovative Approach:
The clearance from the FDA marks a significant milestone in Evolution Devices’ journey to advance movement therapy with cutting-edge affordable technologies that enable anyone, anywhere to receive personalized rehabilitative care. The company’s goal is to improve the lives of individuals with mobility challenges. The FDA clearance signifies that EvoWalk meets FDA’s high standards of safety and effectiveness, validating the hard work and dedication of the team behind this life-changing technology.
With FDA clearance achieved, Evolution Devices is now accelerating production to meet the growing demand for EvoWalk. The company will begin servicing the more than one thousand individuals who have expressed their interest by joining the EvoWalk interest list.
For more information about EvoWalk, its impact, and how to invest, partner, or support our mission, please visit www.evolutiondevices.com or contact info@evolutiondevices.com.
Pierluigi Mantovani, Co-Founder and CEO at Evolution Devices:
“Our journey began with a vision to make walking a natural, effortless part of daily life for those struggling with mobility issues. Receiving FDA 510(k) clearance is not just a professional achievement for us; it’s a symbol of hope for millions who can benefit from EvoWalk.”
Juan Rodriguez, Co-Founder and CTO at Evolution Devices:
“EvoWalk stands out due to its ability to understand and adapt to an individual’s walking pattern, thereby facilitating smoother and more stable steps. EvoWalk’s design is rooted in cutting-edge technology, extensively tested and researched to ensure its efficacy and safety. The device is more than a mobility aid; it’s a testament to the power of innovation driven by empathy and a deep understanding of the real-world needs of its users.”
EJ Gann, PT, DPT, NCS, Senior Instructor, University of Colorado Anschutz Medical Campus:
“The EvoWalk is an innovative functional electrical stimulation (FES) device which enables clinicians to monitor and progress FES intervention remotely, while also providing important data about the user’s gait cycle which can be used to inform clinical decisions.”
Valerie Gibson, PT, DPT, Founder of Advanced Physical Therapy and Rehabilitation Center:
“What I like about EvoWalk is the ease of application, compact size, and the ability to stimulate more than one muscle group with a single unit versus using separate lower leg cuff and thigh cuff.”
About Evolution Devices
Evolution Devices was founded in 2017 with a mission to evolve movement therapy with cutting-edge affordable technologies that enable anyone, anywhere to receive personalized rehabilitative care. Co-Founder Pierluigi Mantovani was motivated to start Evolution Devices as a solution to his father’s declining mobility due to his multiple sclerosis. The company now consists of a multidisciplinary team of experts in neuroscience, engineering, data science, robotics, and physical therapy. At Evolution Devices, we believe that technology has the power to transform lives. Our flagship product, EvoWalk™, exemplifies our dedication to this belief. For more information, visit www.evolutiondevices.com and www.republic.co/evolution-devices.
Evolution Devices Press Release
Media Contact:
Pierluigi Mantovani
Co-Founder and CEO of Evolution Devices
(661) 993-0685
pierluigi@evolutiondevices.com
LinkedIn
SOURCE: Evolution Devices
View the original press release on accesswire.com
Miami, Florida--(Newsfile Corp. - December 21, 2024) - Amid the vibrant backdrop of Art Basel…
Daily Fit Notes, founded by Justin Brey in New York, launches a text-based subscription fitness…
MT. STERLING, Ohio, Dec. 20, 2024 /PRNewswire/ -- WillowWood, a global leader in prosthetic solutions,…
TORONTO, ON / ACCESSWIRE / December 20, 2024 / Quantum BioPharma Ltd. (NASDAQ:QNTM)(CSE:QNTM)(FRA:0K91) ("Quantum BioPharma"…
Toronto, Ontario--(Newsfile Corp. - December 20, 2024) - Glow Lifetech Corp. (CSE: GLOW) (OTC Pink:…
Toronto, Ontario--(Newsfile Corp. - December 20, 2024) - Bloom Burton & Co. Inc. (Bloom Burton)…