innovation

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

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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

FDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation

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FDA Releas­es Arti­fi­cial Intelligence/Machine Learn­ing Action Plan (FDA press release):

Today, the U.S. Food and Drug Admin­is­tra­tion released the agency’s first Arti­fi­cial Intelligence/Machine Learn­ing (AI/ML)-Based Soft­ware as a Med­ical Device (SaMD) Action Plan. This action plan describes a mul­ti-pronged approach to advance the Agency’s over­sight of AI/ML-based med­ical soft­ware … The AI/ML-Based Soft­ware as a Med­ical Device Action Plan out­lines five actions that the FDA intends to take, including:

  • Fur­ther devel­op­ing the pro­posed reg­u­la­to­ry frame­work, includ­ing through issuance of draft guid­ance on a pre­de­ter­mined change con­trol plan (for software’s learn­ing over time);

[Read more…] about FDA releas­es first Arti­fi­cial Intel­li­gence (AI) reg­u­la­to­ry plan to pro­mote respon­si­ble dig­i­tal health innovation

Update: Four tips to practice good mental hygiene during the coronavirus outbreak

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Time for a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing this time 14 time­ly news and resources for men­tal health and brain health innovation.

First of all, let’s remain safe, healthy, and cen­tered dur­ing the cur­rent health cri­sis by fol­low­ing these tips pro­vid­ed by the Greater Good Sci­ence Cen­ter at UC Berkeley:

1. Stay calm and focused
2. Pay atten­tion to those doing the right thing
3. Show gratitude
4. Remem­ber our com­mon bonds

1) “Of course, all of these guide­lines don’t sup­plant the impor­tance of prac­tic­ing good hygiene. We need to con­tin­ue to fre­quent­ly wash our hands and avoid touch­ing our faces, so that we can lessen the chance of infect­ing our­selves and oth­ers. But we also should remem­ber our men­tal hygiene—staying calm our­selves, being grate­ful espe­cial­ly to those doing the right thing, and remem­ber­ing our com­mon human­i­ty. In this way, we can help to make the world safer for all of us.” Four tips to prac­tice good men­tal hygiene dur­ing the coro­n­avirus outbreak

2) “Before any­thing else, prepa­ra­tion is the key to success.”
–Alexan­der Gra­ham Bell

Thank­ful­ly, neu­rotech pio­neer Tan Le out­lines sev­er­al areas where we can take a prac­ti­cal approach to address changes already under­way and lay the ground­work for a more seam­less tran­si­tion to a new era. Fast For­ward to 2040: How to pre­pare for the new era in brain enhance­ment that will change the way we think, work, and heal

3) Here’s a beau­ti­ful way to explore the anato­my of brain regions and brain func­tions. The Vir­tu­al Brain Web Atlas: How the Mind emerges from the Brain

4) “Before stu­dents decide to slip in their ear­buds, though, they should care­ful­ly con­sid­er both their musi­cal selec­tion and the nature of the task” … because “We found that (1) music gen­er­al­ly impaired com­plex task per­for­mance, (2) com­plex music facil­i­tat­ed sim­ple task per­for­mance, and (3) pref­er­ence for exter­nal stim­u­la­tion mod­er­at­ed these effects. There­fore, the data sug­gest that music’s effects on task per­for­mance depend on the music, the task, and the per­former” Does music facil­i­tate or impair cog­ni­tive task per­for­mance? It depends…

5) Because learn­ing can­not, must not, ever stop: Meet the Top 50 final­ists for the Glob­al Teacher Prize 2020

6) Any plans for the sum­mer? Four ways hik­ing pro­motes cog­ni­tive and emo­tion­al health

7) Har­ness­ing tech to pro­mote social con­nect­ed­ness: Every Wednes­day start­ing today we can join scientist/ entre­pre­neur Rana el Kaliou­by online to dis­cuss her new book! Vir­tu­al book tour to explore the fron­tier of Emo­tion­al Intel­li­gence and Technology

8) On-field or off-field, train­ing goes on: Sports teams find cre­ative ways to cross-train the brain off-field

9) “You Can’t Man­age What You Can’t Mea­sure” has­n’t yet reached pub­lic health … but it will. To screen, or not to screen (for demen­tia), that is still the question

10) Sum­ma­riz­ing a recent study, “children’s sleep should be eval­u­at­ed as part of an ADHD eval­u­a­tion as sleep dif­fi­cul­ties are more com­mon … address­ing sleep issues in chil­dren with ADHD is a fea­si­ble and rel­a­tive­ly low-cost approach that can be a valu­able treat­ment com­po­nent for many chil­dren.” Study: A brief sleep inter­ven­tion can bring mea­sur­able and sus­tained ben­e­fits to chil­dren with ADHD

11) Some may and will dis­agree, but net net this offers a major oppor­tu­ni­ty to har­ness smart­phone use data for good: Ver­i­ly and LivaNo­va accel­er­ate efforts to detect and treat depression

12) Poten­tial big news in the neu­ro­mod­u­la­tion mar­ket; coro­n­avirus or not we all have awe­some brains and will expe­ri­ence brain/ men­tal health needs in the future: Medtron­ic might acquire LivaNova’s neu­ro­mod­u­la­tion business

13) What if “An employ­er wants to reduce the risk of on-the-job dis­abil­i­ty, so it screens appli­cants for neu­ro­log­i­cal mark­ers that they are pre­dis­posed to chron­ic pain and depres­sion…” Let’s antic­i­pate the poten­tial mis­use of neu­ro­log­i­cal data to min­i­mize the risks–and max­i­mize the benefits

14) The first brain teaser/ test here is espe­cial­ly rel­e­vant these days … Sev­en fun brain teasers to hon­or our unique Brains and Minds dur­ing Brain Aware­ness Week 2020

 

Have a good and healthy Spring,

The Sharp­Brains Team

Mindstrong Health recruits slew of Silicon Valley talent

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– Mind­strong Health is apply­ing machine learn­ing meth­ods on human-smart­phone inter­ac­tions to iden­ti­fy dig­i­tal phe­no­typ­ing fea­tures that could be clin­i­cal­ly useful.

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Mind­strong Health Expands Exec­u­tive Team to Advance Tech­nol­o­gy for New Vir­tu­al Men­tal Health Care Mod­el (press release):

“Mind­strong Health, a health­care inno­va­tion com­pa­ny ded­i­cat­ed to trans­form­ing men­tal health through inno­va­tions in dig­i­tal mea­sure­ment and vir­tu­al care mod­els, today announced the addi­tion of ten senior exec­u­tives to its lead­er­ship team includ­ing CEO Daniel Graf, who joined the com­pa­ny in Octo­ber 2019.”

On top of Mr. Graf, Mind­strong Health has also recruit­ed: [Read more…] about Mind­strong Health recruits slew of Sil­i­con Val­ley talent

December 5–6th in Dublin: 2nd European Annual Virtual Reality and Healthcare Symposium

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Just a heads-up about a great event lat­er this week in Dublin, Ire­land, for those work­ing on vir­tu­al and aug­ment­ed real­i­ty and health­care innovation.

When: Thu Dec 5, 2019 8:00 am — Fri Dec 6, 2019 5:00 pm.

Where: Dav­en­port Hotel

Featured sessions include:

[Read more…] about Decem­ber 5–6th in Dublin: 2nd Euro­pean Annu­al Vir­tu­al Real­i­ty and Health­care Symposium

Debate: What are the ethics of discouraging much-needed innovation given potential privacy concerns?

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CNN’s Ana Maria Mon­tero inter­views Ned Sahin. The dis­cus­sion about the impact of EU pri­va­cy laws starts in minute 10.

Sto­ry descrip­tion (CNN Mon­ey): Ned Sahin is founder and CEO of neu­rotech­nol­o­gy start-up Brain Pow­er, whose tool “Empow­er Me” uses smart glass­es like Google Glass to coach those with autism. It helps school­child­ren learn social and cog­ni­tive skills and can even guide adults through an inter­view process. Brain Power’s prod­uct is sold to many schools in the U.S. but may nev­er make it to mar­ket in Switzer­land [Read more…] about Debate: What are the ethics of dis­cour­ag­ing much-need­ed inno­va­tion giv­en poten­tial pri­va­cy concerns?