The digital health ecosystem has swelled to encompass a broad range of products over the years.
On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time worrying about oversight from the Federal Trade Commission than the health regulator. [Read more…] about Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA
Founded in 2012, Happify is best known for digital programs that provided automated self-guided support across various areas of mental health and wellness, such as stress management for employees or health plan members. Should the user need additional support, the platform can also facilitate a referral to third-party coaching, therapy, telemedicine or other available resources. [Read more…] about Happify Health raises $73M to deepen partnerships with pharmaceutical companies and insurance payers
Alzheimer’s Prediction May Be Found in Writing Tests (The New York Times):
… the researchers looked at a group of 80 men and women in their 80s — half had Alzheimer’s and the others did not. But, seven and a half years earlier, all had been cognitively normal. [Read more…] about Study: Artificial intelligence program identifies linguistic markers that predict, with 70% accuracy, who gets Alzheimer’s Disease years later
Welcome to a new edition of SharpBrains’ e‑newsletter, featuring a life well lived, the latest news on brain health and innovation, and some brain teasers in honor of International Brain Teaser Month.
#1. Thank you, Sharon. We won’t. “Never stop wondering” — Sharon Begley, science journalist, RIP
#2. Write injuries in sand, kindnesses in ____________.
Milk the cow, but do not pull off the ___________.
Enjoy these 5 US and 7 international proverbs to test your cognitive skills.
#3. Beware the snakes as you tease your mind with this optical illusion.
#4. The blood-brain barrier is hopefully hard at work: Can COVID-19 coronavirus “invade” human brain tissue? (Quick answer: evidence so far is mixed)
#5. Yes, a bit circular…but that’s the point: To manage stress, sleep better. To sleep better, keep a good routine and manage stress.
#6. Excellent article for those interested in state-of-the-art neurotech. The Promise of Big Data Imaging for Mental Health
#7. We’d much rather see the NIH or a fitness or nutrition company sponsor such a promising study, rather than a pharma company, but this is great news anyway: The new frontier in neurocognitive monitoring and dementia screening: the Apple Watch
#8. “I am encouraged by Cognito’s innovative approach,” said Allan Levey, M.D., Ph.D., Professor and Chairman of the Department of Neurology at Emory University and Director of the Emory Goizueta Alzheimer’s Disease Research Center. “This strategy translating recent advances in non-invasive modulation of brain activity with sensory stimulation with light and sound has the potential to be an urgently needed safe, non-invasive, and effective treatment for millions of individuals with Alzheimer’s disease.” Neurostimulation device GammaSense by Cognito Therapeutics secures FDA Breakthrough Device Designation to explore Alzheimer’s Disease applications
#9. This can help a ton of people, given that “Currently, video EEG is the gold standard for seizure detection, but it requires a hospital stay, is often costly, and can be stigmatizing.” Study: Wearable sensors and machine learning may well (one day) help detect a broad range of epileptic seizures
#10. “While 66% accuracy may not sound high, it is an improvement on current accuracy levels of diagnosis by human clinicians, particularly general physicians who aren’t trained in psychiatry.” Machine learning study finds standardized brain scan biomarker to detect depression with 66% accuracy
#11. FDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation. Two of the priorities are the “issuance of draft guidance on a predetermined change control plan (for software’s learning over time)” and “Developing methods to evaluate and improve machine learning algorithms.” Both are crucial given that data-driven innovation is in flux by definition, unlike drug-driven innovation.
#12. The law of averages suggests 2021 will be a good year … Here’s a toast to a Healthy, Happy & Meaningful New Year.
The SharpBrains Team
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);
Mental and degenerative disorders are among the most costly and common causes of disability in society today. Because the brain is the most complex organ in the human body, diagnosing and treating problems when things go wrong poses enormous challenges. Even before the 1990s was designated the Decade of the Brain, the potential of neuroimaging—the technology that makes it possible to see inside the working brain—was a major focus in [Read more…] about Neuroimaging, big data and mental health: A survey of the land