Avation Medical Gains ISO 13485 Quality Standard Certification

Avation Medical has received the International Organization for Standardization (ISO) 13485 certification for its Quality Management System after an extensive audit of its facilities. The audit was conducted by TÜV SÜD America, Inc., an independent third-party certification firm. 
 
ISO 13485 certification recognizes companies that demonstrate high-quality design, production, representation, and servicing of regulated medical devices.
 
The company also launched its new Vivally System, the first FDA-cleared non-invasive, physiological closed-loop neuromodulation system to treat overactive bladder (OAB) without surgery or drugs.
 
“The ISO certification represents a milestone confirming that the revolutionary Vivally System, with its physiologic closed-loop system, is managed and delivered under the highest quality conditions,” said Manish Vaishya, PhD, chief technology officer and co-founder at Avation Medical. “Vivally is currently being prescribed to patients in the U.S. with symptoms of OAB and this new certification opens the door for our international expansion.”
 
Vivally uses algorithms and electromyographical (EMG) sensors to read patients’ EMG signals. The device automatically adjusts the level of stimulation energy being delivered to a patient’s tibial nerve to ensure optimal, customized therapy in a real-time, closed-loop system. 
 
Vivally is worn on the ankle and is used by patients at home for therapy sessions lasting only 30 minutes as little as once per week. Because Vivally requires no surgery, drugs, or needles, it represents a groundbreaking advancement in the treatment of OAB.
 
The system went through two multi-center randomized clinical trials, which showed a significant reduction in incontinence, and urgency episodes and improved patient quality of life while facilitating an 89-percent therapy compliance rate. Symptom reduction was demonstrated out to one year, even with decreasing therapy frequency over time.