CyMedica Orthopedics Receives FDA Clearance for e-vive Therapy

By Julie A. Vetalice

CyMedica Orthopedics received FDA 510(k) clearance for e-vive™, an app-controlled, data-driven muscle activation therapy and patient engagement solution for anterior cruciate ligament and total knee replacement patients.

The app works with embedded garment sensor technology to transmit data points (e.g. range of motion, activity levels, pain scores, etc.) directly to a secure cloud-based portal, allowing providers to track patient progress and patient-reported measures.

In 2015, the company received CE Mark approval for QB1™, a neuromuscular electrical stimulation (NMES) system for the treatment of quadriceps muscle atrophy. The QB1 device combines a post-op knee brace, form-fitting conductive garment and user-friendly stimulation control interface to simplify delivery of "at home" NMES treatment and patient compliance.

Sources: CyMedica Orthopedics; ORTHOWORLD Inc.

Product Labels: Traditional Soft Tissue Repair, Knee Replacement

Tags: 510(k) Clearance, Regulatory