• Skip to main content
  • Skip to primary sidebar

Tracking Health and Wellness Applications of Brain Science

Spanish
sb-logo-with-brain
  • Resources
    • Monthly eNewsletter
    • Solving the Brain Fitness Puzzle
    • The SharpBrains Guide to Brain Fitness
    • How to evaluate brain training claims
    • Resources at a Glance
  • Brain Teasers
    • Top 25 Brain Teasers & Games for Teens and Adults
    • Brain Teasers for each Cognitive Ability
    • More Mind Teasers & Games for Adults of any Age
  • Virtual Summits
    • 2019 SharpBrains Virtual Summit
    • Speaker Roster
    • Brainnovations Pitch Contest
    • 2017 SharpBrains Virtual Summit
    • 2016 SharpBrains Virtual Summit
    • 2015 SharpBrains Virtual Summit
    • 2014 SharpBrains Virtual Summit
  • Report: Pervasive Neurotechnology
  • Report: Digital Brain Health
  • About
    • Mission & Team
    • Endorsements
    • Public Speaking
    • In the News
    • Contact Us

digital health

The FDA ends precertification (Pre-Cert) pilot program, saying new authority required to regulate software as a medical device (SaMD)

December 20, 2022 by SharpBrains Leave a Comment

FDA acknowl­edges short­com­ings of Pre-Cert pilot in report (Reg­u­la­to­ry Focus):

The US Food and Drug Admin­is­tra­tion (FDA) said it needs addi­tion­al Con­gres­sion­al author­i­ty to move for­ward with its dig­i­tal health pre­cer­ti­fi­ca­tion (Pre-Cert) pro­gram. While the idea has been wide­ly laud­ed by var­i­ous stake­hold­ers, at least one expert said he feels vin­di­cat­ed for warn­ing the agency ear­ly on that it lacked the legal author­i­ty to ful­ly imple­ment pathway.

In 2017, the FDA pro­posed the idea of a Pre-Cert pro­gram that would act as a new path­way for soft­ware as a med­ical device (SaMD) prod­ucts, through which the agency could green-light such prod­ucts based on how much reg­u­la­tors trust the man­u­fac­tur­er. The agency has been run­ning a pilot pro­gram to test the fea­si­bil­i­ty of the pro­gram, but in a new report, FDA con­cedes it does not have the legal author­i­ty need­ed to cre­ate the pro­gram as orig­i­nal­ly envi­sioned. [Read more…] about The FDA ends pre­cer­ti­fi­ca­tion (Pre-Cert) pilot pro­gram, say­ing new author­i­ty required to reg­u­late soft­ware as a med­ical device (SaMD)

Share this:

  • Tweet
  • Email
  • Print
  • More
  • Share on Tumblr
  • Pock­et

Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: digital health, FDA, Pre-Cert, precertification, software as a medical device, US Food and Drug Administration

On mental fitness beliefs, lifestyles and new tools like apps, digital therapeutics, virtual reality, “brain age gaps” and more

May 31, 2022 by SharpBrains

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing time­ly brain & men­tal health news and a fun cou­ple of math brain teasers.

#1. Study on the “ABCs of Men­tal Health” finds that sim­ply believ­ing you can improve men­tal well­be­ing helps actu­al­ly improve it

Beliefs mat­ter.

#2. “Dig­i­tal ther­a­peu­tics” vs. “Men­tal health apps”: A grow­ing debate on stan­dards, reg­u­la­tion and efficacy

Def­i­n­i­tions matter.

#3. How ’sleep­ing on it’ can help the pre­frontal cor­tex reg­u­late emo­tion­al respons­es, mak­ing us feel bet­ter in the morning

Sleep mat­ters.

#4. NICE in the UK issues rec­om­men­da­tion for Sleepio app, the dig­i­tal cog­ni­tive behav­iour­al ther­a­py for insom­nia by Big Health

Inno­va­tion mat­ters: “At a price of £45 per per­son, Sleepio is cost sav­ing com­pared with usu­al treat­ment in pri­ma­ry care. This is based on an analy­sis of pri­ma­ry care resource use data before and after Sleepio was intro­duced in 9 GP prac­tices. Health­care costs were low­er at 1 year, most­ly because of few­er GP appoint­ments and sleep­ing pills prescribed.”

#5. New book pro­vides prac­ti­cal guid­ance for women (and men) to rebal­ance our lifestyles and build Cog­ni­tive Reserve

Lifestyle mat­ters: “The more com­plex our lives are, the more we need sim­ple things that can ground us and help us to be more resilient – to rebal­ance and rebal­ance and rebal­ance again. Build­ing the men­tal mus­cles to find bal­ance when one gets off bal­ance is a crit­i­cal skill thrive and to build cog­ni­tive reserve in our fast-chang­ing times. As our month­ly gath­er­ings showed us over the years, prac­tic­ing rebal­ance in good com­pa­ny not only rein­forces neur­al path­ways and capa­bil­i­ties but also strength­ens the bonds of trust and con­fi­dence that are invalu­able to build a healthy envi­ron­ment to thrive in.”

#6. Study: Auto­mat­ed VR psy­chother­a­py can help reduce anx­i­ety and dis­tress, espe­cial­ly among those with psy­chosis and severe agoraphobia

One of the ben­e­fits of VR is that patients know they are in a sim­u­la­tion, which enables “psy­cho­log­i­cal dis­tance from prob­lem­at­ic reac­tions,” the study authors wrote. “The process of find­ing the best uses and imple­men­ta­tion meth­ods of this immer­sive tech­nol­o­gy at scale in men­tal health is only beginning.”

#7. Fund­ing for dig­i­tal health start-ups, espe­cial­ly in men­tal health, fall sub­stan­tial­ly in Q1’22

“While all tech sec­tors received small­er fund­ing totals than the pre­vi­ous quar­ter, dig­i­tal health plunged much fur­ther than oth­ers did … investor inter­est in men­tal health tech wavered as the mar­ket and pub­lic com­pa­nies like Talk­space and Cere­bral come under scrutiny.”

#8. Deep learn­ing mod­el built on neu­roimag­ing data iden­ti­fies “Brain Age Gaps” as mark­ers of Alzheimer’s dis­ease (AD)

“The main find­ing of our study is that we could indeed find evi­dence that high brain age gap is behav­ing as an accel­er­at­ed brain aging bio­mark­er.” — Dr. David Jones, neu­rol­o­gist at Mayo Clinic

Final­ly, a cou­ple fun brain teasers to help you flex your math/ cog­ni­tive men­tal muscles:

#9. Will you fin­ish your the­sis on time?

#10. Math brain teas­er requir­ing no math — just per­cep­tion and cognition

 

Wish­ing you and yours a healthy and stim­u­lat­ing June!

Share this:

  • Tweet
  • Email
  • Print
  • More
  • Share on Tumblr
  • Pock­et

Filed Under: Brain/ Mental Health, SharpBrains Monthly eNewsletter, Technology & Innovation Tagged With: apps, biomarker, brain age gaps, brain aging biomarker, Brain Teasers, brain-aging, cognitive, digital health, digital therapeutics, mental health, mental muscles, mental-fitness, sleep, virtual-reality

“Digital therapeutics” vs. “Mental health apps”: A growing debate on standards, regulation and efficacy

May 9, 2022 by SharpBrains

The effi­ca­cy of Men­tal Health Apps (phar­mafo­rum):

In Jan­u­ary, PLOS Dig­i­tal Health pub­lished a study which claimed that there’s “sparse” data to sup­port the effi­ca­cy of most men­tal health apps.

In their meta-analy­sis of pub­lished stud­ies, the authors found uni­ver­sal defi­cien­cies and con­clud­ed that there’s no con­vinc­ing evi­dence that app-based inter­ven­tions deliv­er mean­ing­ful out­comes. With­out dig­ging fur­ther, one might think the cur­rent case for dig­i­tal ther­a­peu­tics is weak.

I reviewed all 14 meta-analy­ses includ­ed in the study and found the analy­sis to be accu­rate, but incom­plete. [Read more…] about “Dig­i­tal ther­a­peu­tics” vs. “Men­tal health apps”: A grow­ing debate on stan­dards, reg­u­la­tion and efficacy

Share this:

  • Tweet
  • Email
  • Print
  • More
  • Share on Tumblr
  • Pock­et

Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: Big Health, digital health, digital therapeutics, Digital Therapeutics Alliance, DTx, FDA, Happify Health, mental health apps, mental illness, meta-analysis, Orexo, PEAR, PLOS Digital Health

Funding for digital health start-ups, especially in mental health, fall substantially in Q1’22

May 3, 2022 by SharpBrains

Glob­al dig­i­tal health fund­ing falls 36% with few­er megarounds, IPOs (Fierce Healthcare):

After two years of record-break­ing invest­ment in dig­i­tal health, cap­i­tal flow into the sec­tor took a dive in the first quar­ter of 2022.

The glob­al dig­i­tal health mar­ket saw fund­ing decrease 36% from the fourth quar­ter of 2021, total­ing $10.4 bil­lion, as investors react­ed to sup­ply chain woes, the Russ­ian inva­sion of Ukraine and a volatile stock mar­ket, accord­ing to a new CB Insights report. [Read more…] about Fund­ing for dig­i­tal health start-ups, espe­cial­ly in men­tal health, fall sub­stan­tial­ly in Q1’22

Share this:

  • Tweet
  • Email
  • Print
  • More
  • Share on Tumblr
  • Pock­et

Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: cerebral, digital health, digital health market, market, Mental Health Tech, Talkspace

A conversation at the frontier of digital health innovation, FDA regulations, and cognitive health

March 23, 2022 by SharpBrains

Dig­i­tal Ther­a­peu­tics for MCI and Alzheimer’s dis­ease: A Reg­u­la­to­ry Per­spec­tive (The Jour­nal of Pre­ven­tion of Alzheimer’s Disease):

–This arti­cle is adapt­ed from a com­pre­hen­sive con­ver­sa­tion between Dr. Murali Doraiswamy and Dr. Jef­frey Shuren at the 2021 Clin­i­cal Tri­als on Alzheimer’s Dis­ease (CTAD) con­fer­ence in Boston. Dr. Shuren is a behav­ioral neu­rol­o­gist who has held a vari­ety of lead­er­ship roles at the FDA and CMS, includ­ing as Direc­tor of the Cen­ter for Devices and Radi­o­log­i­cal Health (CDRH).

MD: The CDRH has a flag­ship Dig­i­tal Health Cen­ter of Excel­lence. Can you tell us about it? And can you share your advice for how the Alzheimer’s field can help spur dig­i­tal inno­va­tion? [Read more…] about A con­ver­sa­tion at the fron­tier of dig­i­tal health inno­va­tion, FDA reg­u­la­tions, and cog­ni­tive health

Share this:

  • Tweet
  • Email
  • Print
  • More
  • Share on Tumblr
  • Pock­et

Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: Alzheimer’s Disease, CDRH, cognitive-health, CTAD, digital health, Digital Health Center of Excellence, digital health innovation, Dr. Jeffrey Shuren, Dr. Murali Doraiswamy, FDA, innovation, MCI, precertification

Wearable EEG monitoring start-up Epitel raises $12.5M to market seizure detection system

February 22, 2022 by SharpBrains

Epi­tel rais­es $12.5M for wear­able seizure detec­tion sys­tem (Mobi­Health News):

Epi­tel, mak­er of a wear­able elec­troen­cephalo­gram (EEG) sys­tem for seizure detec­tion, announced Wednes­day it had scored $12.5 mil­lion in Series A funding.

The round was led by Cat­a­lyst Health Ven­tures (CHV) and Genoa Ven­tures, with par­tic­i­pa­tion from Dex­com, OSF Ven­tures, Wave­mak­er 360, Med­Moun­tain Ven­tures and Salt Lake City Angels … The com­pa­ny’s first prod­uct, the REMI sys­tem, con­sists of a wear­able, wire­less EEG sen­sor that’s applied below the hair­line, and soft­ware for providers to review data and mon­i­tor for seizures. The sen­sor can con­tin­u­ous­ly mon­i­tor patients for 48 hours. [Read more…] about Wear­able EEG mon­i­tor­ing start-up Epi­tel rais­es $12.5M to mar­ket seizure detec­tion system

Share this:

  • Tweet
  • Email
  • Print
  • More
  • Share on Tumblr
  • Pock­et

Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: digital brain health, digital health, Epitel, FDA, FDA 510(k) clearance, REMI, seizure detection, wearable EEG, wearable electroencephalogram

Next Page »

Primary Sidebar

Top Articles on Brain Health and Neuroplasticity

  1. Can you grow your hippocampus? Yes. Here’s how, and why it matters
  2. How learning changes your brain
  3. To harness neuroplasticity, start with enthusiasm
  4. Three ways to protect your mental health during –and after– COVID-19
  5. Why you turn down the radio when you're lost
  6. Solving the Brain Fitness Puzzle Is the Key to Self-Empowered Aging
  7. Ten neu­rotech­nolo­gies about to trans­form brain enhance­ment & health
  8. Five reasons the future of brain enhancement is digital, pervasive and (hopefully) bright
  9. What Educators and Parents Should Know About Neuroplasticity and Dance
  10. The Ten Habits of Highly Effective Brains
  11. Six tips to build resilience and prevent brain-damaging stress
  12. Can brain training work? Yes, if it meets these 5 conditions
  13. What are cognitive abilities and how to boost them?
  14. Eight Tips To Remember What You Read
  15. Twenty Must-Know Facts to Harness Neuroplasticity and Improve Brain Health

Top 10 Brain Teasers and Illusions

  1. You think you know the colors? Try the Stroop Test
  2. Check out this brief attention experiment
  3. Test your stress level
  4. Guess: Are there more brain connections or leaves in the Amazon?
  5. Quick brain teasers to flex two key men­tal mus­cles
  6. Count the Fs in this sentence
  7. Can you iden­tify Apple’s logo?
  8. Ten classic optical illu­sions to trick your mind
  9. What do you see?
  10. Fun Mental Rotation challenge
  • Check our Top 25 Brain Teasers, Games and Illusions

Join 12,620 readers exploring, at no cost, the latest in neuroplasticity and brain health.

By subscribing you agree to receive our free, monthly eNewsletter. We don't rent or sell emails collected, and you may unsubscribe at any time.

IMPORTANT: Please check your inbox or spam folder in a couple minutes and confirm your subscription.

Get In Touch!

Contact Us

660 4th Street, Suite 205,
San Francisco, CA 94107 USA

About Us

SharpBrains is an independent market research firm tracking health and performance applications of brain science. We prepare general and tailored market reports, publish consumer guides, produce an annual global and virtual conference, and provide strategic advisory services.

© 2022 SharpBrains. All Rights Reserved - Privacy Policy