Digitsole Pro® is FDA Registered Class II

Innovative AI-Based Solution for Clinical Assessment of Mobility Disorders

Sunnyvale, Ca (October 25, 2021) – Digitsole, a leader in the digital health space bringing together digital mobility biomarkers and biomechanical data with clinical expertise, has received Class II medical device registration with the U.S. Food and Drug Administration (FDA) for its Digitsole Pro® smart insoles. Digitsole Pro®, recently launched in the United States, is a solution, developed with, and for healthcare professionals to improve the clinical assessment of patients with mobility disorders.

Digitsole Pro® is an important assessment advancement that can help improve a patient's walking or running, and advance recovery from neurological, orthopedic, age-related or sport-related conditions. It measures objective biomechanical data not observable by the naked eye. Patient movements translate into Digitsole Pro's proprietary artificial intelligence (AI) algorithm and become relevant clinical data providing more effective treatment options for mobility disorders.

Digitsole Pro® uses the smallest foot inertial measurement unit module in the world, the DSMotion, to evaluate the quantitative and qualitative impact of movement to improve patient health.

Digitsole Pro® software is an intuitive application that empowers practitioners to analyze patients’ musculoskeletal performance.

Each Digitsole Pro® insole has an inertial platform that records the walking steps, running strides, and orientations of a foot in space. The proprietary AI algorithms process this data to calculate the spatiotemporal, kinematic, and advanced parameters displayed in the digital interface. The connected chips inserted into a patient’s insoles send the data collected at the end of each activity. The biomechanical results of the analysis are clearly understandable and are available within a few minutes for practical application.

"We developed Digitsole Pro® with healthcare practitioners, and now more than 700 clinicians around the world are using Digitsole Pro® as their in-clinic digital partner," says Christian Dupont, CEO, Digitsole. "We are excited to launch Digitsole Pro® in the U.S. with FDA approval, as our team continues its work on extracting the full potential of real-world mobility data."

To learn more and request a free demo, visit https://www.digitsolepro.com


A digital health company started in 2015 in France; Digitsole is a leader in the e-health space, bringing together digital mobility biomarkers and biomechanical data with clinical expertise to improve the wellbeing of people throughout their lives. Digitsole developed their digital health platform to monitor effortlessly mobility measurements and related pathologies. Digitsole's mission is to empower mobility for a healthier life, and the company knows real-world data can advance wellness and lead to better health predictions. Visit https://www.digitsole.com for more information.

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