STAT-ON Obtains TGA Approval for Commercialization in Australia: A Major Milestone in Parkinson’s Care

STAT-ON, the innovative wearable Holter for Parkinson’s disease, has received approval from the Therapeutic Goods Administration (TGA) for commercialization in hashtag Australia. This marks a significant regulatory milestone and paves the way for the device to become available to healthcare professionals and patients across the country. Designed for continuous, real-world monitoring of motor symptoms, STAT-ON is worn discreetly on the waist and provides objective data to support more informed clinical decisions in the management of Parkinson’s disease.

The TGA’s endorsement affirms the quality, safety, and clinical value of STAT-ON, validating years of development and rigorous evaluation. The approval allows neurologists and movement disorder specialists in Australia to incorporate STAT-ON into their routine practice, enabling more personalized and data-driven treatment strategies. By capturing motor fluctuations and mobility patterns in a patient’s natural environment, STAT-ON helps bridge the gap between in-clinic assessments and everyday symptom variability, a critical aspect in optimizing Parkinson’s care.

This milestone represents a major achievement for the company behind STAT-ON and underscores its commitment to expanding access to precision monitoring technologies globally. The Australian market opens up new opportunities for collaboration within the Asia-Pacific region and strengthens the company’s position as a leader in digital health solutions for neurodegenerative diseases.

The TGA approval is not only a testament to the device’s clinical relevance but also a step forward in the mission to improve quality of life for people living with Parkinson’s worldwide.