FDA grants breakthrough device designation to NeuraMetrix (press release):
“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 … The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.
- To learn more, visit the FDA page Here