Getting FDA Approval is Hot Topic at Neurogaming Conference

Wandering through booths at a neurogaming conference in downtown San Francisco this week was a little like finding myself in a science fiction infomercial.

This was the  the fourth annual Experiential Technology & NeuroGaming Conference and Expo, where I mingled with neuroscientists and inventors, eager to explain the technology behind their multiwired headsets or sleek brain gadgets.

Products fell into three primary categories:

• This Product Will Improve Your Life: 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.
• For Entertainment Only: 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.
• This Product is Therapeutic: 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.

Apps Headed to Hospitals and Clinics

Here’s a round-up of four companies who attended. They're offering products your doctor may suggest or even prescribe in the future.

Pear Therapeutics' 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.”

Vivid Vision offers 3-D video games for people with lazy eye, cross-eye or convergence insufficiency.  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.

"I am not a doctor and I haven't proven that my game will work for anyone," Blaha told Fast Company. "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.

AppliedVR 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 Institutional Review Board approved clinical studies with Cedars-Sinai and Children’s Hospital Los Angeles.

Akili Interactive 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.

Pros and Cons of the FDA Route

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.

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.

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 “deceptive conduct in the future.”

Future of You's Jon Brooks recently reported on Lumos Labs:

“I think claims these companies have been making—and Lumosity is not alone—have been grossly exaggerated,” Dr. Laura Carstensen, founding director of the Stanford Center on Longevity 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.”

This assessment is pretty much in line with the 2014 Stanford Center’s critique of the so-called brain-training industry. Called “A Consensus on the Brain Training Industry From the Scientific Community,” it was signed by dozens of scientists in the field.

“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.”

"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."