FDA Grants Breakthrough Device Designation to NeuraMetrix

NeuraMetrix Newsletter

January 21, 2019

Parkinson’s disease measurement solution granted Breakthrough Device designation by FDA


The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to the NeuraMetrix brain health monitoring solution. The designation is granted for devices “that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions”. The approved use is monitoring of Parkinson’s disease (PD) to more effectively treat patients with PD, which is a significant challenge for neurologists today as they only see the patient a few times a year.

PD is a debilitating chronic condition that affects hundreds of thousands of lives globally. Although there is no cure for PD, early detection, disease management and proper treatment can provide significant relief. “The breakthrough device designation reaffirms that the NeuraMetrix brain monitoring solution could enable better treatment of patients by providing more precise and timely feedback,” said Jan Samzelius, chief executive officer of NeuraMetrix.

The NeuraMetrix’ digital biomarker measures inconsistency of typing cadence (the rhythm of how we type on a keyboard) - a proven indicator of brain health. Clinical data has demonstrated that NeuraMetrix may be effective for Central Nervous System (CNS) diseases such as PD, Alzheimer’s disease (AD) and Depression.

About the Breakthrough Devices Program

Description: The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. To learn more, visit the FDA page Here

About Parkinson’s disease

More than 10M people worldwide (whereof nearly 1M in the U.S.) are living with PD. Approximately 60,000 Americans are diagnosed with PD each year. The combined direct and indirect cost of PD, including treatment, social security payments and lost income, is estimated to be nearly $25 billion per year in the United States alone. To learn more, visit the Parkinson's Foundation page Here.

About NeuraMetrix

NeuraMetrix, Inc. is a San Francisco based medical device company, which provides precise and accurate measurement of brain health over time. NeuraMetrix’s unique technology enables,

  • Neurologists to manage patients on a continuous basis,

  • Integrates quickly and easily into current clinical practice, and

  • Allows for rapid adoption for screening large patient populations

NeuraMetrix’s roadmap includes adding support for other brain diseases such as AD, Depression and Multiple Sclerosis; and offers solutions for early detection of these diseases.

For more information and to learn how you can get involved, please visit https://www.neurametrix.com.