Getting FDA Approval is Hot Topic at Neurogaming Conference
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She has won several regional Emmy awards, a regional and a national Edward R. Murrow award. The Association for Health Journalists awarded Lesley best beat coverage. The Society of Professional Journalists has recognized her reporting several times. The Society of Environmental Journalists spotlighted her ongoing coverage of California's historic drought. \u003c/span>\u003cspan style=\"font-weight: 400;\">Before joining KQED in 2016, she covered food and sustainability for Capital Public Radio, the environment for Colorado Public Radio, and reported for both KUOW and KCTS9 in Seattle. \u003c/span>\u003cspan style=\"font-weight: 400;\">When not hunched over her laptop Lesley enjoys skiing with her toddler, surfing with her husband or scheming their next globetrotting adventure. Before motherhood she relished dancing tango till sunrise. When on deadline she fuels herself almost exclusively on chocolate chips.\u003c/span>\r\n\r\n\u003cspan style=\"font-weight: 400;\"> \u003c/span>","avatar":"https://secure.gravatar.com/avatar/3fb78e873af3312f34d0bc1d60a07c7f?s=600&d=blank&r=g","twitter":"lesleywmcclurg","facebook":null,"instagram":null,"linkedin":null,"sites":[{"site":"arts","roles":["author"]},{"site":"news","roles":["editor"]},{"site":"futureofyou","roles":["editor"]},{"site":"stateofhealth","roles":["author"]},{"site":"science","roles":["editor"]}],"headData":{"title":"Lesley McClurg | KQED","description":"KQED Health Correspondent","ogImgSrc":"https://secure.gravatar.com/avatar/3fb78e873af3312f34d0bc1d60a07c7f?s=600&d=blank&r=g","twImgSrc":"https://secure.gravatar.com/avatar/3fb78e873af3312f34d0bc1d60a07c7f?s=600&d=blank&r=g"},"isLoading":false,"link":"/author/lesleymcclurg"}},"breakingNewsReducer":{},"campaignFinanceReducer":{},"firebase":{"requesting":{},"requested":{},"timestamps":{},"data":{},"ordered":{},"auth":{"isLoaded":false,"isEmpty":true},"authError":null,"profile":{"isLoaded":false,"isEmpty":true},"listeners":{"byId":{},"allIds":[]},"isInitializing":false,"errors":[]},"navBarReducer":{"navBarId":"home","fullView":true,"showPlayer":false},"navMenuReducer":{"menus":[{"key":"menu1","items":[{"name":"News","link":"/","type":"title"},{"name":"Politics","link":"/politics"},{"name":"Science","link":"/science"},{"name":"Education","link":"/educationnews"},{"name":"Housing","link":"/housing"},{"name":"Immigration","link":"/immigration"},{"name":"Criminal Justice","link":"/criminaljustice"},{"name":"Silicon Valley","link":"/siliconvalley"},{"name":"Forum","link":"/forum"},{"name":"The California Report","link":"/californiareport"}]},{"key":"menu2","items":[{"name":"Arts & Culture","link":"/arts","type":"title"},{"name":"Critics’ Picks","link":"/thedolist"},{"name":"Cultural Commentary","link":"/artscommentary"},{"name":"Food & Drink","link":"/food"},{"name":"Bay Area Hip-Hop","link":"/bayareahiphop"},{"name":"Rebel Girls","link":"/rebelgirls"},{"name":"Arts Video","link":"/artsvideos"}]},{"key":"menu3","items":[{"name":"Podcasts","link":"/podcasts","type":"title"},{"name":"Bay Curious","link":"/podcasts/baycurious"},{"name":"Rightnowish","link":"/podcasts/rightnowish"},{"name":"The Bay","link":"/podcasts/thebay"},{"name":"On Our Watch","link":"/podcasts/onourwatch"},{"name":"Mindshift","link":"/podcasts/mindshift"},{"name":"Consider This","link":"/podcasts/considerthis"},{"name":"Political Breakdown","link":"/podcasts/politicalbreakdown"}]},{"key":"menu4","items":[{"name":"Live Radio","link":"/radio","type":"title"},{"name":"TV","link":"/tv","type":"title"},{"name":"Events","link":"/events","type":"title"},{"name":"For Educators","link":"/education","type":"title"},{"name":"Support KQED","link":"/support","type":"title"},{"name":"About","link":"/about","type":"title"},{"name":"Help Center","link":"https://kqed-helpcenter.kqed.org/s","type":"title"}]}]},"pagesReducer":{},"postsReducer":{"stream_live":{"type":"live","id":"stream_live","audioUrl":"https://streams.kqed.org/kqedradio","title":"Live Stream","excerpt":"Live Stream information currently unavailable.","link":"/radio","featImg":"","label":{"name":"KQED Live","link":"/"}},"stream_kqedNewscast":{"type":"posts","id":"stream_kqedNewscast","audioUrl":"https://www.kqed.org/.stream/anon/radio/RDnews/newscast.mp3?_=1","title":"KQED Newscast","featImg":"","label":{"name":"88.5 FM","link":"/"}},"futureofyou_166123":{"type":"posts","id":"futureofyou_166123","meta":{"index":"posts_1591205157","site":"futureofyou","id":"166123","score":null,"sort":[1463770522000]},"guestAuthors":[],"slug":"to-fda-or-not-to-fda-is-hot-topic-at-neurogaming-conference","title":"Getting FDA Approval is Hot Topic at Neurogaming Conference","publishDate":1463770522,"format":"standard","headTitle":"Future of You | KQED Future of You | KQED Science","labelTerm":{"term":54,"site":"futureofyou"},"content":"\u003cp>Wandering through booths at a neurogaming conference in downtown San Francisco this week was a little like finding myself in a science fiction infomercial.\u003c/p>\n\u003cp>This was the the fourth annual \u003ca href=\"http://www.xtechexpo.com/\" target=\"_blank\">Experiential Technology & NeuroGaming Conference and Expo\u003c/a>, where I mingled with neuroscientists and inventors, eager to explain the technology behind their multiwired headsets or sleek brain gadgets.\u003c/p>\n\u003caside class=\"pullquote alignright\">'There is a lot of noise out there and there is really no way for patients, or clinicians or for anyone to know what works and what doesn’t. We really think that FDA is the gold standard to really speak to clinicians.'\u003ccite>Corey McCann, Pear Therapeutics\u003c/cite>\u003c/aside>\n\u003cp>Products fell into three primary categories:\u003c/p>\n\u003cul>\n\u003cli>\u003cstrong>This Product Will Improve Your Life:\u003c/strong> In the life enhancement category, there were a number of devices that reps claimed would help me meditate, focus or train more efficiently. In one booth, attendees sat on black leather cushions, eyes closed and listening to guided meditations on black headsets. When listeners became distracted -- as determined by brain wave tracking -- the volume increased. In another booth, athletes tested the virtual reality devices that Stanford quarterbacks are using to help them prepare for games.\u003c/li>\n\u003cli>\u003cstrong>For Entertainment Only:\u003c/strong> PlayStation sponsored the most popular entertainment booth, where a long line of people were buzzing about the upcoming fall release of the company's virtual reality games. When my turn came, the rep tightened my headset, and suddenly I was immersed in the deep of the ocean. When an animated shark opened its giant jaw and swam straight at me, I screamed.\u003c/li>\n\u003cli>\u003cstrong>This Product is Therapeutic:\u003c/strong> A number of companies are targeting the medical field through an emerging market called digital therapeutics. Devices, apps and video games were on display targeting more serious mental conditions like attention deficit hyperactivity disorder or autism. Some are even seeking approval from the FDA.\u003c/li>\n\u003c/ul>\n\u003cp>\u003cstrong>Apps Headed to Hospitals and Clinics\u003c/strong>\u003c/p>\n\u003cp>Here’s a round-up of four companies who attended. They're offering products your doctor may suggest or even \u003cem>prescribe\u003c/em> in the future.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I think this is going to play out a lot like the drug versus supplement route.'\u003ccite>Corey McCann, Pear Therapeutics\u003c/cite>\u003c/aside>\n\u003cfigure id=\"attachment_166550\" class=\"wp-caption alignleft\" style=\"max-width: 250px\">\u003cimg class=\"wp-image-166550\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/pear-400x244.jpg\" alt=\"pear\" width=\"250\" height=\"153\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/05/pear-400x244.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/pear.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/pear-768x468.jpg 768w\" sizes=\"(max-width: 250px) 100vw, 250px\">\u003cfigcaption class=\"wp-caption-text\">Users can track their medicine with Pear Therapeutics' smartphone app. \u003ccite>(Pear Therapeutics)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003ca href=\"https://peartherapeutics.com/\">\u003cb>Pear Therapeutics'\u003c/b>\u003c/a> primary product is called Reset. It’s an app that a doctor must prescribe to treat substance abuse or addiction. Patients can log cravings, triggers and drugs, or take learning modules to train themselves in new behaviors. Clinicians can log on and follow the patient’s progress. The app isn't on the market yet because it's been submitted to the FDA for approval. The company has spent about $40 million on five clinical studies with about 1,500 patients. If all goes well, CEO Corey McCann says he expects approval sometime this year. “There is a lot of noise out there and there is really no way for patients, or clinicians or for anyone to know what works and what doesn’t,” says McCann. “We really think that FDA is the gold standard to really speak to clinicians.”\u003c/p>\n\u003cfigure id=\"attachment_166553\" class=\"wp-caption alignleft\" style=\"max-width: 250px\">\u003cimg class=\"wp-image-166553\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-400x184.png\" alt=\"The equipment (computer, headset and software) you'll need to use Vivid Vision. \" width=\"250\" height=\"115\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-400x184.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-800x367.png 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-768x353.png 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-1180x542.png 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-960x441.png 960w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle.png 1599w\" sizes=\"(max-width: 250px) 100vw, 250px\">\u003cfigcaption class=\"wp-caption-text\">The equipment (computer, headset and software) you'll need to use Vivid Vision. \u003ccite>(Vivid Vision)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003ca href=\"https://www.seevividly.com/\">\u003cb>Vivid Vision\u003c/b>\u003c/a> offers 3-D video games for people with lazy eye, cross-eye or \u003ca href=\"http://www.convergenceinsufficiency.org/\" target=\"_blank\">convergence insufficiency\u003c/a>. When you visit the company's website, it directs you to the closest eye clinic that carries the software, which must be prescribed by a doctor. The company was a dream for CEO James Blaha, whose eyes don't align normally.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"I am not a doctor and I haven't proven that my game will work for anyone,\" Blaha told \u003ca href=\"http://www.fastcompany.com/3025877/fast-feed/using-leap-motion-and-oculus-rift-this-game-tries-to-correct-lazy-eye\" target=\"_blank\">Fast Company\u003c/a>. \"That being said, I am working on doing studies to catalog any of the benefits of playing Diplopia, and playing it has improved the vision in my amblyopic eye substantially.\" He says the company eventually will pursue FDA approval because he'd like insurance carriers to be able to reimburse patients for the software.\u003c/p>\n\u003cfigure id=\"attachment_166554\" class=\"wp-caption alignleft\" style=\"max-width: 250px\">\u003cimg class=\"wp-image-166554\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/2d3d421c-patientvr.png\" alt=\"Patient watching AppliedVR game. \" width=\"250\" height=\"133\">\u003cfigcaption class=\"wp-caption-text\">Patient watching AppliedVR app. \u003ccite>(Applied VR)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003ca href=\"http://www.appliedvr.net/\">\u003cb>AppliedVR\u003c/b>\u003c/a> offers two virtual reality apps aimed at reducing patient anxiety or pain through immersive distraction. The app leads a patient into another world to take their mind off a surgery before, during and after the procedure. The company is launching pilot studies in several medical facilities. “We have not yet taken steps toward FDA approval,\" says Josh Sackman, AppliedVR's president. \"We don't believe it's initially necessary given the types of applications we are launching.” He says he's considering seeking FDA approval in the future. Meanwhile, Sackman says the device is being tested in \u003ca href=\"http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm\">Institutional Review Board\u003c/a> approved clinical studies with Cedars-Sinai and Children’s Hospital Los Angeles.\u003c/p>\n\u003cfigure id=\"attachment_166555\" class=\"wp-caption alignleft\" style=\"max-width: 139px\">\u003cimg class=\"wp-image-166555\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/evo-phone-400x811.png\" alt=\"Akili's Project Evo smartphone video game.\" width=\"139\" height=\"282\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/05/evo-phone-400x811.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/evo-phone-296x600.png 296w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/evo-phone.png 500w\" sizes=\"(max-width: 139px) 100vw, 139px\">\u003cfigcaption class=\"wp-caption-text\">Akili's Project Evo smartphone video game. \u003ccite>(Alkili)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003ca href=\"http://www.akiliinteractive.com/\">\u003cb>Akili Interactive\u003c/b>\u003c/a> developed a video game called Project Evo, which is intended to help players ignore distractions and focus. The company is targeting patients with ADHD, autism, depression and traumatic brain injury. The premise is that improving cognitive skills will in turn, relieve painful symptoms associated with cognitive disorders. The product is in final FDA device trials at 10 clinical sites. CEO Eddie Martucci says the company chose the highly regulated route to assure the end user, clinicians and insurers that the product works.\u003c/p>\n\u003cp>\u003cstrong>Pros and Cons of the FDA Route\u003c/strong>\u003c/p>\n\u003cp>All four of the CEOs listed above were on a panel discussing the merits and risks of choosing FDA approval. They all agreed it depends on money, time and target market.\u003c/p>\n\u003cp>It's much quicker to penetrate the market and get your product in the hands of consumers if a company chooses the unregulated route. FDA approval of a medical device can take three to five years, and that's light years in the world of technology.\u003c/p>\n\u003cp>But the recent government crackdown on the company Lumos Labs points to another risk of not seeking government approval. The Federal Trade Commission penalized Lumos for falsely claiming its online games could delay cognitive impairments like Alzheimer's, dementia and memory loss. The company had to pay $2 million for partial customer refunds and is prohibited from “\u003ca href=\"https://www.ftc.gov/system/files/documents/public_statements/903353/160104lumositystatement.pdf\" target=\"_blank\">deceptive conduct in the future\u003c/a>.”\u003c/p>\n\u003cp>Future of You's Jon Brooks recently \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/15/lumosity-cant-prove-claims-say-scientists-but-brain-training-worth-researching/\">reported\u003c/a> on Lumos Labs:\u003c/p>\n\u003cblockquote>\u003cp>“I think claims these companies have been making—and Lumosity is not alone—have been grossly exaggerated,” Dr. Laura Carstensen, founding director of the \u003ca href=\"http://longevity3.stanford.edu/\" target=\"_blank\">Stanford Center on Longevity\u003c/a> told KQED's Jon Brooks recently. “They’re trying to argue that we’re going to take you out of that active world … and that we’re going to put you in a room alone in front of a computer screen and you’ll play a game that will make you smarter, and you’re going to pay us to do it.”\u003c/p>\n\u003cp>This assessment is pretty much in line with the 2014 Stanford Center’s critique of the so-called brain-training industry. Called “\u003ca href=\"http://longevity3.stanford.edu/blog/2014/10/15/the-consensus-on-the-brain-training-industry-from-the-scientific-community-2/\" target=\"_blank\">A Consensus on the Brain Training Industry From the Scientific Community\u003c/a>,” it was signed by dozens of scientists in the field.\u003c/p>\n\u003cp>“To date, there is little evidence that playing brain games improves underlying broad cognitive abilities,” the analysis said, “or that it enables one to better navigate a complex realm of everyday life.”\u003c/p>\u003c/blockquote>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\"I think this is going to play out a lot like the drug versus supplement route,\" says Corey McCann, CEO of Pear Therapeutics. \"There will be some products that have some data and there will probably be a premium price that is associated with them. Physicians will be comfortable using them, and payers will feel comfortable reimbursing for them. And you'll have other products that are not backed by data, and that's the more supplement approach or direct-to-consumer approach.\"\u003c/p>\n\n","blocks":[],"excerpt":"New companies designing apps and video games for medical conditions weigh the benefits of going the FDA route. ","status":"publish","parent":0,"modified":1476850163,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":21,"wordCount":1327},"headData":{"title":"Getting FDA Approval is Hot Topic at Neurogaming Conference | KQED","description":"New companies designing apps and video games for medical conditions weigh the benefits of going the FDA route. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Getting FDA Approval is Hot Topic at Neurogaming Conference","datePublished":"2016-05-20T18:55:22.000Z","dateModified":"2016-10-19T04:09:23.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"166123 http://ww2.kqed.org/futureofyou/?p=166123","disqusUrl":"https://ww2.kqed.org/futureofyou/2016/05/20/to-fda-or-not-to-fda-is-hot-topic-at-neurogaming-conference/","disqusTitle":"Getting FDA Approval is Hot Topic at Neurogaming Conference","path":"/futureofyou/166123/to-fda-or-not-to-fda-is-hot-topic-at-neurogaming-conference","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Wandering through booths at a neurogaming conference in downtown San Francisco this week was a little like finding myself in a science fiction infomercial.\u003c/p>\n\u003cp>This was the the fourth annual \u003ca href=\"http://www.xtechexpo.com/\" target=\"_blank\">Experiential Technology & NeuroGaming Conference and Expo\u003c/a>, where I mingled with neuroscientists and inventors, eager to explain the technology behind their multiwired headsets or sleek brain gadgets.\u003c/p>\n\u003caside class=\"pullquote alignright\">'There is a lot of noise out there and there is really no way for patients, or clinicians or for anyone to know what works and what doesn’t. We really think that FDA is the gold standard to really speak to clinicians.'\u003ccite>Corey McCann, Pear Therapeutics\u003c/cite>\u003c/aside>\n\u003cp>Products fell into three primary categories:\u003c/p>\n\u003cul>\n\u003cli>\u003cstrong>This Product Will Improve Your Life:\u003c/strong> In the life enhancement category, there were a number of devices that reps claimed would help me meditate, focus or train more efficiently. In one booth, attendees sat on black leather cushions, eyes closed and listening to guided meditations on black headsets. When listeners became distracted -- as determined by brain wave tracking -- the volume increased. In another booth, athletes tested the virtual reality devices that Stanford quarterbacks are using to help them prepare for games.\u003c/li>\n\u003cli>\u003cstrong>For Entertainment Only:\u003c/strong> PlayStation sponsored the most popular entertainment booth, where a long line of people were buzzing about the upcoming fall release of the company's virtual reality games. When my turn came, the rep tightened my headset, and suddenly I was immersed in the deep of the ocean. When an animated shark opened its giant jaw and swam straight at me, I screamed.\u003c/li>\n\u003cli>\u003cstrong>This Product is Therapeutic:\u003c/strong> A number of companies are targeting the medical field through an emerging market called digital therapeutics. Devices, apps and video games were on display targeting more serious mental conditions like attention deficit hyperactivity disorder or autism. Some are even seeking approval from the FDA.\u003c/li>\n\u003c/ul>\n\u003cp>\u003cstrong>Apps Headed to Hospitals and Clinics\u003c/strong>\u003c/p>\n\u003cp>Here’s a round-up of four companies who attended. They're offering products your doctor may suggest or even \u003cem>prescribe\u003c/em> in the future.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I think this is going to play out a lot like the drug versus supplement route.'\u003ccite>Corey McCann, Pear Therapeutics\u003c/cite>\u003c/aside>\n\u003cfigure id=\"attachment_166550\" class=\"wp-caption alignleft\" style=\"max-width: 250px\">\u003cimg class=\"wp-image-166550\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/pear-400x244.jpg\" alt=\"pear\" width=\"250\" height=\"153\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/05/pear-400x244.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/pear.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/pear-768x468.jpg 768w\" sizes=\"(max-width: 250px) 100vw, 250px\">\u003cfigcaption class=\"wp-caption-text\">Users can track their medicine with Pear Therapeutics' smartphone app. \u003ccite>(Pear Therapeutics)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003ca href=\"https://peartherapeutics.com/\">\u003cb>Pear Therapeutics'\u003c/b>\u003c/a> primary product is called Reset. It’s an app that a doctor must prescribe to treat substance abuse or addiction. Patients can log cravings, triggers and drugs, or take learning modules to train themselves in new behaviors. Clinicians can log on and follow the patient’s progress. The app isn't on the market yet because it's been submitted to the FDA for approval. The company has spent about $40 million on five clinical studies with about 1,500 patients. If all goes well, CEO Corey McCann says he expects approval sometime this year. “There is a lot of noise out there and there is really no way for patients, or clinicians or for anyone to know what works and what doesn’t,” says McCann. “We really think that FDA is the gold standard to really speak to clinicians.”\u003c/p>\n\u003cfigure id=\"attachment_166553\" class=\"wp-caption alignleft\" style=\"max-width: 250px\">\u003cimg class=\"wp-image-166553\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-400x184.png\" alt=\"The equipment (computer, headset and software) you'll need to use Vivid Vision. \" width=\"250\" height=\"115\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-400x184.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-800x367.png 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-768x353.png 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-1180x542.png 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle-960x441.png 960w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Vivid_Vision_for_Amblyopia_Box_and_Bundle.png 1599w\" sizes=\"(max-width: 250px) 100vw, 250px\">\u003cfigcaption class=\"wp-caption-text\">The equipment (computer, headset and software) you'll need to use Vivid Vision. \u003ccite>(Vivid Vision)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003ca href=\"https://www.seevividly.com/\">\u003cb>Vivid Vision\u003c/b>\u003c/a> offers 3-D video games for people with lazy eye, cross-eye or \u003ca href=\"http://www.convergenceinsufficiency.org/\" target=\"_blank\">convergence insufficiency\u003c/a>. When you visit the company's website, it directs you to the closest eye clinic that carries the software, which must be prescribed by a doctor. The company was a dream for CEO James Blaha, whose eyes don't align normally.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"I am not a doctor and I haven't proven that my game will work for anyone,\" Blaha told \u003ca href=\"http://www.fastcompany.com/3025877/fast-feed/using-leap-motion-and-oculus-rift-this-game-tries-to-correct-lazy-eye\" target=\"_blank\">Fast Company\u003c/a>. \"That being said, I am working on doing studies to catalog any of the benefits of playing Diplopia, and playing it has improved the vision in my amblyopic eye substantially.\" He says the company eventually will pursue FDA approval because he'd like insurance carriers to be able to reimburse patients for the software.\u003c/p>\n\u003cfigure id=\"attachment_166554\" class=\"wp-caption alignleft\" style=\"max-width: 250px\">\u003cimg class=\"wp-image-166554\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/2d3d421c-patientvr.png\" alt=\"Patient watching AppliedVR game. \" width=\"250\" height=\"133\">\u003cfigcaption class=\"wp-caption-text\">Patient watching AppliedVR app. \u003ccite>(Applied VR)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003ca href=\"http://www.appliedvr.net/\">\u003cb>AppliedVR\u003c/b>\u003c/a> offers two virtual reality apps aimed at reducing patient anxiety or pain through immersive distraction. The app leads a patient into another world to take their mind off a surgery before, during and after the procedure. The company is launching pilot studies in several medical facilities. “We have not yet taken steps toward FDA approval,\" says Josh Sackman, AppliedVR's president. \"We don't believe it's initially necessary given the types of applications we are launching.” He says he's considering seeking FDA approval in the future. Meanwhile, Sackman says the device is being tested in \u003ca href=\"http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm\">Institutional Review Board\u003c/a> approved clinical studies with Cedars-Sinai and Children’s Hospital Los Angeles.\u003c/p>\n\u003cfigure id=\"attachment_166555\" class=\"wp-caption alignleft\" style=\"max-width: 139px\">\u003cimg class=\"wp-image-166555\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/evo-phone-400x811.png\" alt=\"Akili's Project Evo smartphone video game.\" width=\"139\" height=\"282\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/05/evo-phone-400x811.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/evo-phone-296x600.png 296w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/evo-phone.png 500w\" sizes=\"(max-width: 139px) 100vw, 139px\">\u003cfigcaption class=\"wp-caption-text\">Akili's Project Evo smartphone video game. \u003ccite>(Alkili)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003ca href=\"http://www.akiliinteractive.com/\">\u003cb>Akili Interactive\u003c/b>\u003c/a> developed a video game called Project Evo, which is intended to help players ignore distractions and focus. The company is targeting patients with ADHD, autism, depression and traumatic brain injury. The premise is that improving cognitive skills will in turn, relieve painful symptoms associated with cognitive disorders. The product is in final FDA device trials at 10 clinical sites. CEO Eddie Martucci says the company chose the highly regulated route to assure the end user, clinicians and insurers that the product works.\u003c/p>\n\u003cp>\u003cstrong>Pros and Cons of the FDA Route\u003c/strong>\u003c/p>\n\u003cp>All four of the CEOs listed above were on a panel discussing the merits and risks of choosing FDA approval. They all agreed it depends on money, time and target market.\u003c/p>\n\u003cp>It's much quicker to penetrate the market and get your product in the hands of consumers if a company chooses the unregulated route. FDA approval of a medical device can take three to five years, and that's light years in the world of technology.\u003c/p>\n\u003cp>But the recent government crackdown on the company Lumos Labs points to another risk of not seeking government approval. The Federal Trade Commission penalized Lumos for falsely claiming its online games could delay cognitive impairments like Alzheimer's, dementia and memory loss. The company had to pay $2 million for partial customer refunds and is prohibited from “\u003ca href=\"https://www.ftc.gov/system/files/documents/public_statements/903353/160104lumositystatement.pdf\" target=\"_blank\">deceptive conduct in the future\u003c/a>.”\u003c/p>\n\u003cp>Future of You's Jon Brooks recently \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/15/lumosity-cant-prove-claims-say-scientists-but-brain-training-worth-researching/\">reported\u003c/a> on Lumos Labs:\u003c/p>\n\u003cblockquote>\u003cp>“I think claims these companies have been making—and Lumosity is not alone—have been grossly exaggerated,” Dr. Laura Carstensen, founding director of the \u003ca href=\"http://longevity3.stanford.edu/\" target=\"_blank\">Stanford Center on Longevity\u003c/a> told KQED's Jon Brooks recently. “They’re trying to argue that we’re going to take you out of that active world … and that we’re going to put you in a room alone in front of a computer screen and you’ll play a game that will make you smarter, and you’re going to pay us to do it.”\u003c/p>\n\u003cp>This assessment is pretty much in line with the 2014 Stanford Center’s critique of the so-called brain-training industry. Called “\u003ca href=\"http://longevity3.stanford.edu/blog/2014/10/15/the-consensus-on-the-brain-training-industry-from-the-scientific-community-2/\" target=\"_blank\">A Consensus on the Brain Training Industry From the Scientific Community\u003c/a>,” it was signed by dozens of scientists in the field.\u003c/p>\n\u003cp>“To date, there is little evidence that playing brain games improves underlying broad cognitive abilities,” the analysis said, “or that it enables one to better navigate a complex realm of everyday life.”\u003c/p>\u003c/blockquote>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"I think this is going to play out a lot like the drug versus supplement route,\" says Corey McCann, CEO of Pear Therapeutics. \"There will be some products that have some data and there will probably be a premium price that is associated with them. Physicians will be comfortable using them, and payers will feel comfortable reimbursing for them. And you'll have other products that are not backed by data, and that's the more supplement approach or direct-to-consumer approach.\"\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/166123/to-fda-or-not-to-fda-is-hot-topic-at-neurogaming-conference","authors":["11229"],"programs":["futureofyou_54"],"categories":["futureofyou_1060","futureofyou_1063","futureofyou_1061"],"tags":["futureofyou_930","futureofyou_929","futureofyou_928"],"featImg":"futureofyou_166621","label":"futureofyou_54"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. 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But is this once sleepy suburb ready for them?","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/American-Suburb-Podcast-Tile-703x703-1.jpg","officialWebsiteLink":"/news/series/american-suburb-podcast","meta":{"site":"news","source":"kqed","order":"13"},"link":"/news/series/american-suburb-podcast/","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?mt=2&id=1287748328","tuneIn":"https://tunein.com/radio/American-Suburb-p1086805/","rss":"https://ww2.kqed.org/news/series/american-suburb-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkMzMDExODgxNjA5"}},"baycurious":{"id":"baycurious","title":"Bay Curious","tagline":"Exploring the Bay Area, one question at a time","info":"KQED’s new podcast, Bay Curious, gets to the bottom of the mysteries — both profound and peculiar — that give the Bay Area its unique identity. And we’ll do it with your help! You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Bay-Curious-Podcast-Tile-703x703-1.jpg","imageAlt":"\"KQED Bay Curious","officialWebsiteLink":"/news/series/baycurious","meta":{"site":"news","source":"kqed","order":"4"},"link":"/podcasts/baycurious","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/bay-curious/id1172473406","npr":"https://www.npr.org/podcasts/500557090/bay-curious","rss":"https://ww2.kqed.org/news/category/bay-curious-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvbmV3cy9jYXRlZ29yeS9iYXktY3VyaW91cy1wb2RjYXN0L2ZlZWQvcG9kY2FzdA","stitcher":"https://www.stitcher.com/podcast/kqed/bay-curious","spotify":"https://open.spotify.com/show/6O76IdmhixfijmhTZLIJ8k"}},"bbc-world-service":{"id":"bbc-world-service","title":"BBC World Service","info":"The day's top stories from BBC News compiled twice daily in the week, once at weekends.","airtime":"MON-FRI 9pm-10pm, TUE-FRI 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/BBC-World-Service-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.bbc.co.uk/sounds/play/live:bbc_world_service","meta":{"site":"news","source":"BBC World Service"},"link":"/radio/program/bbc-world-service","subscribe":{"apple":"https://itunes.apple.com/us/podcast/global-news-podcast/id135067274?mt=2","tuneIn":"https://tunein.com/radio/BBC-World-Service-p455581/","rss":"https://podcasts.files.bbci.co.uk/p02nq0gn.rss"}},"code-switch-life-kit":{"id":"code-switch-life-kit","title":"Code Switch / Life Kit","info":"\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />","airtime":"SUN 9pm-10pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Code-Switch-Life-Kit-Podcast-Tile-360x360-1.jpg","meta":{"site":"radio","source":"npr"},"link":"/radio/program/code-switch-life-kit","subscribe":{"apple":"https://podcasts.apple.com/podcast/1112190608?mt=2&at=11l79Y&ct=nprdirectory","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93d3cubnByLm9yZy9yc3MvcG9kY2FzdC5waHA_aWQ9NTEwMzEy","spotify":"https://open.spotify.com/show/3bExJ9JQpkwNhoHvaIIuyV","rss":"https://feeds.npr.org/510312/podcast.xml"}},"commonwealth-club":{"id":"commonwealth-club","title":"Commonwealth Club of California Podcast","info":"The Commonwealth Club of California is the nation's oldest and largest public affairs forum. 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