FDA draft guidance on BCI devices. The FDA signaled its interest in the development of implanted brain-computer interface (BCI) devices on Friday with the release of a new draft guidance focused on the emerging technology. The new document suggests that non-clinical testing of the devices could precede clinical testing as a means to identify and prevent potential risks prior to use by patients.
“The draft guidance is considered a ‘leap-frog’ guidance because it helps bridge where we are today with innovations of tomorrow, providing our initial thoughts about regulatory considerations for an emerging health technology with the understanding that our recommendations are likely to evolve as the FDA works to finalize the guidance to account for public comments, technological developments and new information,” FDA Commissioner Dr. Scott Gottlieb said 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 can alter the paradigm for how we approach certain medical challenges and advance these goals.”
…
Not just for Spanish homework. A paper published yesterday in JAMA Internal Medicine suggests that Google Translate is generally up to snuff when converting patient discharge instructions from English into Spanish or Chinese. Among the sample of 100 ER discharge instructions examined by UCSF’s Dr. Elaine C. Khoong and colleagues, Google’s tool was 92 percent accurate when translating into Spanish and 81 percent accurate for Chinese. However, the researchers also noted a 2 percent and 8 percent rate of inaccurate translations that could lead to “serious errors” for the patients.
…
Counting calories. A forthcoming study in the journal Obesity shows that self-monitoring of diet need not be an onerous process. The study of 142 patients showed that recording their diet took patients an average of just 14.6 minutes per day. Furthermore, it was frequency of logging, not time spent logging, that was the biggest predictor of weight loss.
"Those who self-monitored three or more time per day, and were consistent day after day, were the most successful," Jean Harvey, chair of the Nutrition and Food Sciences Department at the University of Vermont and the lead author of the study, said in a statement. "It seems to be the act of self-monitoring itself that makes the difference — not the time spent or the details included.”
The study could have design implications for food-logging apps like LoseIt or MyFitnessPal.
…
HoloLens 2 isn’t alone. California-based augmented reality glasses manufacturer Ocutrx Vision Technologies has announced a new design for its Oculenz AR Wear glasses at Mobile World Congress Barcelona. The lightweight AR glasses have fully integrated eye-tracking and cellular connectivities included alongside floating lenses that the company is initially marketing to patients with macular degeneration and other low vision conditions.
“We wanted the Oculenz design to inspire patients on an emotional level to enable better health outcomes,” Karten Design President and founder Stuart Karten, whose company collaborated with Ocutrx on the headset’s design, said in a statement. “We worked to transform Ocutrx’s technology into a more appealing product that enables people to manage their low vision effectively while leveraging the technology and core design for applications in multiple industries.”
…
Reading between the lines. Education technology software maker GoGuardian has released Beacon, a digital tool for identifying suicide and self harm risks across social media, forums, emails 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 as it does contextual analyses of individuals’ phrases or underlying emotions.
“We know that students primarily communicate, express their feelings, and explore ideas and actions across a variety of places online,” Tyler Shaddix, cofounder and chief product officer at GoGuardian, said in a statement. “Beacon provides K-12 mental health professionals with time-critical information so they can extend an early hand to students facing serious personal challenges. Beacon also provides school professionals with important context and data so they can more confidently assess and manage each individual case.”
…
IPO incoming. Connected exercise equipment maker Peloton is shopping for an underwriter in hopes of a 2019 IPO, the Wall Street Journal reports. The company is thought to be seeking a higher valuation than the $4 billion it was pegged at late last year, and is expected to hit more than $700 million in revenue for the fiscal year ending in February.
…
Protecting trial data with blockchain. UCSF researchers described a proof-of-concept application of blockchain technology that would ensure the integrity of clinical trial data. Published last week in Nature Communications, the system is able to report data such as adverse events to a central regulatory agency in real time while simultaneously preventing any major unauthorized edits.
"A system built upon our prototype could be developed to enable 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 expanded to provide more access to raw data for research scientists, the way we do with ImmPort, or deliver trial results to the public.”
…
Nothing to fear. In a small eight-person pilot study, virtual reality has shown promise in helping adults with autism to cope with fears and phobias. The study, published in the new peer-reviewed journal Autism in Adulthood, exposed patients to four 20-minute sessions of VR, in which they experienced exposure therapy tailored to their particular phobia. All of the patients were able to complete the course of treatment, and five of the eight reported improvements in their ability to deal with their fears in real life contexts.
"Phobias commonly co-occur with autism and often cause significant distress. While results are very preliminary, it is exciting to see innovative strategies for an issue that has been so hard to treat. Emerging Practices papers, such as this one, look towards the future by highlighting new avenues of research that have potential for improving quality of life for autistic adults," Dr. Christina Nicolaidis, editor in chief of Autism in Adulthood, said in a statement.