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Neuroplasticity, Brain Fitness and Cognitive Health News


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


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:

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.

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As seen in The New York Times, The Wall Street Journal, BBC News, CNN, Reuters,  SharpBrains is an independent market research firm tracking how brain science can improve our health and our lives.

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