CyMedica Orthopedics gets FDA 510(k) clearance for e-vive app-based solution

18 January 2017 (Last Updated November 22nd, 2018 11:32)

US-based medical device company CyMedica Orthopedics has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its e-vive, an app-driven solution for pre and post-operative knee surgery rehabilitation.

CyMedica Orthopedics gets FDA 510(k) clearance for e-vive app-based solution

US-based medical device company CyMedica Orthopedics has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its e-vive, an app-driven solution for pre and post-operative knee surgery rehabilitation.

The e-vive wireless muscle stimulation device has been designed as an app-based data-driven muscle activation therapy and patient engagement solution. It is used to treat complications associated with muscle atrophy due to which patients lose 60% of their quad strength after knee surgery.

The new device features an intuitive interface to simplify the virtual operation compatible on any smart phone.

It consists of a conductive garment, with built-in sensor technology which relays critical range of motion data and steps while precisely holding the electrodes in place to ensure effective quadricep activation.

The data are stored in a secure cloud based portal which can be accessed by the healthcare providers to track patient progress and patient reported measures in order to provide more predictable outcomes in a cost-effective way.

Its controller is based on the company’s CyMotion Technology to monitor and control the power delivered to the muscle to ensure comfort and effectiveness.

"The new device features an intuitive interface to simplify the virtual operation compatible on any smart phone."

CyMedica co-founder and Sports Medicine Surgeon at Hospital for Special Surgery Struan Coleman said: My patients now have access to a world-class muscle activation device that not only improves their quadriceps function, but also allows me to remotely monitor the progress of their rehabilitation.

“The e-vive technology captures key data points, such as range of motion, activity levels, pain scores and more.

"Through e-vive I am able to deliver better outcomes both for my patients and for the hospitals supporting the new economics of quality based care"


Image: The e-vive System. Photo: courtesy of CyMedica Orthopedics, Inc.