Evolution Devices’ EvoWalk Device to Rehabilitate Walking Receives FDA 510(k) Clearance

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:

• Innovative AI-Powered Wearable: With its advanced machine learning algorithms, EvoWalk adapts to each user’s unique gait, offering a groundbreaking and personalized walking experience.
• Sleek & Easy-to-use: Designed with direct user input, EvoWalk’s compact, breathable build easily fits under clothing, minimizes sweating, and allows for simple one-handed use.
• One Device, Full Leg Support: The EvoWalk’s two stimulation channels offer comprehensive leg support, aiding both lower and upper leg muscles.
• Data-Driven Care: The EvoWalk mobile app enables patients to engage with their walking data and provides clinicians with actionable data to personalize care.

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 Patients: If you are an individual who could benefit from using EvoWalk, you can join the EvoWalk patient interest list here: https://forms.gle/Q1RWPQRdtvVbp6Y5A
• For Clinicians: If you are a clinician or healthcare provider who would like to bring EvoWalk to their practice, you can join the EvoWalk clinician interest list here: https://forms.gle/afffgzxXxyyyMDqV7

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

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