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

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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

News in Context:

• Five rea­sons the future of brain enhance­ment is dig­i­tal, per­va­sive and (hope­ful­ly) bright
• 10 neu­rotech­nolo­gies about to trans­form brain enhance­ment and brain health
• Info­graph­ic on the Dig­i­tal Brain Health Mar­ket 2012–2020
• FDA clears first CBT-based dig­i­tal ther­a­peu­tic to treat sub­stance abuse disorders
• The FDA cre­ates new Dig­i­tal Health unit to reimag­ine reg­u­la­to­ry paths

Dur­ing Expo Day select­ed Sum­mit Part­ners and Spon­sors show­cased their lat­est ini­tia­tives and solutions.

• Dr. Daniel Perez-Mar­cos, Senior Sci­en­tist at Mind­Maze, pre­sent­ed the Mind­Mo­tion platform–a series of med­ical-grade vir­tu­al real­i­ty solu­tions for neurorehabilitation.
• Alvaro Fer­nan­dez. Sharp­Brains‘ CEO & Edi­tor-in-Chief dis­cussed The State of Brain Health Innovation.
• Mark Wat­son, Co-Direc­tor of the Wat­son Cen­tre for Brain Health, explored lat­est research and pro­grams for cog­ni­tive rehabilitation.

These pre­sen­ta­tions took place at the 2016 Sharp­Brains Vir­tu­al Sum­mit (Decem­ber 6–8th, 2016). Learn more about the 2018 Sharp­Brains Vir­tu­al Sum­mit Here.