software

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

Ohio Opioid Technology Challenge funds program testing neurofeedback-based brain training to reduce cravings and battle opioid addiction

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Soft­ware engi­neer Kel­ly Cash­ion (right) adjusts a wire­less EEG head­set on research engi­neer Nilesh Powar. Cred­it: The Uni­ver­si­ty of Day­ton Research Institute

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Bat­tling Addic­tion With Brain­pow­er (Uni­ver­si­ty of Day­ton press release):

“The Uni­ver­si­ty of Day­ton Research Insti­tute has won a $10,000 Ohio Opi­oid Tech­nol­o­gy Chal­lenge award for a pro­gram that will teach peo­ple with opi­oid addic­tions how to reduce their crav­ings by regain­ing con­trol of their brains.

“Using neu­ro­feed­back, we’ll work with our vol­un­teers to help them learn to reg­u­late activ­i­ty in the part of their brain asso­ci­at­ed with crav­ings and rewire some of those path­ways, allow­ing them to reduce their crav­ings and expe­ri­ence a more ‘nor­mal’ state even with­out opi­oids.” [Read more…] about Ohio Opi­oid Tech­nol­o­gy Chal­lenge funds pro­gram test­ing neu­ro­feed­back-based brain train­ing to reduce crav­ings and bat­tle opi­oid addiction

The FDA creates new Digital Health unit to reimagine regulatory paths in the age of scalable, AI-enhanced innovation

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Med­i­cine Is Going Dig­i­tal. The FDA Is Rac­ing to Catch Up (Wired):

“WHEN BAKUL PATEL start­ed as a pol­i­cy advi­sor in the US Food and Drug Admin­is­tra­tion in 2008, he could pret­ty much pin­point when a prod­uct was going to land in front of the review­ers in his divi­sion. Back when med­ical devices were heavy on the hardware—your pace­mak­ers and your IUDs—it would take man­u­fac­tur­ers years to get them ready for reg­u­la­to­ry approval. FDA review­ers could keep up pret­ty well [Read more…] about The FDA cre­ates new Dig­i­tal Health unit to reimag­ine reg­u­la­to­ry paths in the age of scal­able, AI-enhanced innovation

Monitoring health, wellness and fitness via wearable devices: Key Neurotech Patent #29

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– Illus­tra­tive image from US Patent No. 7,261,690.

Today we are shar­ing a fas­ci­nat­ing 2007 patent assigned to Body­media. (As men­tioned, we are fea­tur­ing a foun­da­tion­al Per­va­sive Neu­rotech patent a day, from old­er to new­er by issue date)

U.S. Patent No. 7,261,690: Appa­ra­tus for mon­i­tor­ing health, well­ness and fitness.

  • Assignee(s): Body­media, Inc.
  • Inventor(s): Eric Teller, John M. Stivoric, Christo­pher D. Kasabach, Christo­pher D. Pacione, John
  • L. Moss, Craig B. Liden
  • Tech­nol­o­gy Cat­e­go­ry: Neuro-monitoring
  • Issue Date: August 28, 2007

SharpBrains’ Take:

The ‘690 patent dis­clos­es an appa­ra­tus for mon­i­tor­ing human health and well­ness, includ­ing men­tal health ele­ments, through a wear­able device with phys­i­o­log­i­cal and con­tex­tu­al (envi­ron­men­tal) sen­sors. [Read more…] about Mon­i­tor­ing health, well­ness and fit­ness via wear­able devices: Key Neu­rotech Patent #29

Microsoft ranked #4 Holder of Pervasive Neurotech Intellectual Property*

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microsoft logoMicrosoft Cor­po­ra­tion is a world­wide leader in soft­ware solu­tions for busi­ness­es and con­sumers.  In addi­tion, Microsoft has expand­ed into enter­tain­ment, gam­ing, tablets, phones, and oth­er com­mu­ni­ca­tion tech­nol­o­gy.  To pro­vide the ide­al expe­ri­ence for users, [Read more…] about Microsoft ranked #4 Hold­er of Per­va­sive Neu­rotech Intel­lec­tu­al Property*

New $100M investment in Canada to accelerate brain health innovation

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Brain_Baycrest

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Brain research at Toron­to health cen­tre gets $100M fund­ing boost in fed­er­al bud­get (Nation­al Post):

“Ottawa is help­ing fund a $100 mil­lion ini­tia­tive with Toronto’s Bay­crest Health Sci­ences to devel­op a nation­al hub for brain research…“Past gen­er­a­tions of adults said they were most con­cerned about can­cer or heart dis­ease. This gen­er­a­tion says they’re most con­cerned about their brains,” said Dr. Reich­man. [Read more…] about New $100M invest­ment in Cana­da to accel­er­ate brain health innovation