FDA clears MindMaze GO neurorehabilitation platform, easing access to continued outpatient therapy

Hopefully you have decent insurance, or your therapists have cobbled something together with Kinect. More likely you will have to figure this all out on your own because NO protocols seem to exist for stroke rehab. Guidelines exist, protocols don't. Guidelines don't have efficacy ratings.
https://sharpbrains.com/blog/2018/06/13/fda-clears-mindmaze-go-neurorehabilitation-platform-easing-access-to-continued-outpatient-therapy/

By: SharpBrains

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MindMaze Consolidates First-ever FDA Approval for Inpatient and Outpatient Neurorehabilitation Therapy (press release):

“MindMaze, a leader in braintech, has today announced that it has obtained FDA clearance to launch its portable neurorehabilitation product, MindMotion™ GO, in the United States. Together with MindMotion PRO (which received FDA clearance in 2017), MindMotion GO is the next offering in the company’s continuum of care, providing gamified neurorehabilitation therapy.

“Now that both MindMotion products have FDA clearance, MindMaze delivers a full spectrum of neuro-care solutions for both inpatient and outpatient recovery for patients in the United States,” said Tej Tadi, CEO and founder of MindMaze. “Our unique capability to safely and securely acquire data through our platform is essential for patient recovery and performance…”

The FDA approval for a series of neurorehabilitation devices that focus on both inpatient and outpatient care is unique…MindMotion GO differs from MindMotion PRO in both its technology and its intended use cases. MindMotion PRO is designed for patients with severe impairments and for early hospital care, allowing for therapeutic activities as early as four days after a neurological incident. MindMotion GO focuses on medium and light severity impairments and also provides continued therapy later in the recovery phase, primarily on an outpatient basis.

Neurological deficits are the leading cause of long-term disability in the United States. Each year nearly 800,000 Americans suffer a stroke, with direct annual costs estimated at $22.8 billion. A recent study estimated that direct and indirect costs associated with neurological diseases are an astounding $800 billion annually in the US.”

The new device:

Name: MindMotion GO

510(k) Premarket Notification:

• Device Classification Name: System, Optical Position/Movement Recording
• Classification Product: Code LXJ
• Date Received: 12/26/2017
• Decision Date: 05/17/2018
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Physical Medicine
• Regulation Description: Measuring exercise equipment