Release Instructions Translated By Google, FDA Releases New Draft Guidance And More Digital Health Bits

Proposed FDA guideline on BCI devices. The FDA signaled its interest in developing implanted brain-computer interface (BCI) devices on Friday with the publication of a new orientation project focused on emerging technology. The new document suggests that non-clinical testing of the devices could precede clinical testing as a way to identify and prevent potential risks before they are used by patients.

“The draft directive is seen as a leapfrog directive because it helps bridge the gap where we are today with the innovations of tomorrow, by providing our first thoughts on regulatory considerations for emerging health, knowing that our recommendations are subject to change as the FDA strives to finalize the guidelines to take into account public comments, technological developments and new information, ”the Commissioner said. of the FDA, Dr. Scott Gottlieb, in a statement. “Our success in improving safety and driving innovation depends, in part, on our ability to quickly identify the potential for future technological breakthroughs that may shift the paradigm of how we approach certain medical challenges and do advance those goals. “

Not just for Spanish homework. An article published yesterday in JAMA Internal Medicine suggests that Google Translate is generally up to par when converting patient output instructions from English to Spanish or Chinese. Among the sample of 100 emergency exit instructions reviewed by UCSF’s Dr Elaine C. Khoong and colleagues, Google’s tool was 92% accurate when translating into Spanish and 81% accurate for the Chinese. However, the researchers also noted a 2% and 8% rate of inaccurate translations that could lead to “serious errors” for patients.

Count calories. A forthcoming study in the journal Obesity shows that eating self-monitoring doesn’t have to be an expensive process. The study of 142 patients showed that recording their diet took patients an average of 14.6 minutes per day. Additionally, it was the frequency of recording, not the time spent recording, that was the greatest predictor of weight loss.

“Those who self-monitored three or more times a day, and were consistent day after day, were most successful,” Jean Harvey, chair of the University’s Department of Nutritional and Food Sciences from Vermont and lead author of the study, said in a statement. “It seems it’s the act of self-surveillance itself that makes the difference – not the time spent or the details included.”

The study could have design implications for food recording apps like LoseIt or MyFitnessPal.

HoloLens 2 is not alone. California-based augmented reality eyewear maker Ocutrx Vision Technologies announced a new design for its Oculenz AR Wear eyewear at the Mobile World Congress in Barcelona. The lightweight AR glasses have fully integrated eye tracking and cellular connectivity, as well as floating lenses that the company initially markets to patients with macular degeneration and other vision disorders.

“We wanted the Oculenz design to inspire patients emotionally to enable better health outcomes,” said Karten Design president and founder Stuart Karten, whose company collaborated with Ocutrx on the design of the headset, in a statement. “We have worked to transform Outrx’s technology into a more attractive product that allows people to effectively manage their low vision while leveraging the technology and basic design for applications across multiple industries. “

Reading between the lines. Educational technology software maker GoGuardian has released Beacon, a digital tool for identifying suicide and self-harm risks on social media, forums, email, and other online sources. The AI-powered product was designed in collaboration with the American Foundation for Suicide Prevention, the American Association of Suicidology, and K-12 school districts, and relies less on keywords than on contextual analyzes of the sentences or underlying emotions of individuals.

“We know that students primarily communicate, express their feelings, and explore ideas and actions in various places online,” said Tyler Shaddix, co-founder and product manager at GoGuardian, in a statement. “Beacon provides K-12 mental health professionals with urgent information so they can quickly help students with serious personal issues. Beacon also provides school professionals with important context and data so they can more confidently assess and manage each individual case.

Incoming IPO. Connected exercise equipment maker Peloton is seeking insurer in hopes of a 2019 IPO, the the Wall Street newspaper reports. The company is believed to be seeking a higher valuation than the $ 4 billion set at the end of last year, and is expected to reach over $ 700 million in revenue for the fiscal year ending February.

Protect test data with blockchain. UCSF researchers have described a proof-of-concept application of blockchain technology that would ensure the integrity of clinical trial data. Posted last week in Nature Communications, the system is able to report data such as adverse events to a central regulator in real time while simultaneously preventing any major unauthorized changes.

“A system based on our prototype could be developed to allow oversight of international clinical trials, for example,” Dr Atul Butte, director of the Bakar Computational Health Sciences Institute at UCSF, said in a statement. “And it could be extended to provide better access to raw data for researchers, like we do with ImmPort, or to provide trial results to the public.”

Nothing to fear. In a small pilot study of eight people, virtual reality showed promise in helping adults with autism cope with fears and phobias. The study, published in the new peer-reviewed journal Autism in Adulthood, exposed patients to four 20-minute VR sessions, during which they underwent exposure therapy tailored to their particular phobia. All patients were able to complete treatment and five of the eight reported improvements in their ability to deal with their fears in real settings.

“Phobias generally coexist with autism and often cause significant distress. Although the results are very preliminary, it is exciting to see innovative strategies for a problem that has been so difficult to deal with. Emerging practice papers, like this one, look to the future by highlighting new avenues of research that can improve the quality of life for adults with autism, ”said Dr Christina Nicolaidis, editor at chief of Autism in Adulthood, in a statement.

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