Showing all posts written by Benjamin Ho
Benjamin attended college at New York University, where he graduated with degrees in both Computer Science and Economics. He received his Juris Doctor from Cornell Law School, where he was Managing Editor of the Journal of Law and Public Policy.
Benjamin worked as a summer associate at the firm in 2016 and joined the firm in 2017.
Garmin and ActiGraph Collaborate to Explore Health and Activity Monitoring Solutions on Wearable Devices
Garmin International, Inc. recently announced a collaboration with ActiGraph to create health and activity monitoring solutions for academic research, clinical trials, and remote patient monitoring. The collaboration will combine Garmin wearables with ActiGraph‘s CentrePoint data analytics platform to achieve these goals.
Travis Johnson, Garmin Health global product lead, stated that “[c]ombining the sensor data from Garmin wearables with the data capture and analytical expertise of the ActiGraph platform creates a powerful solution for many different patient monitoring applications.”
ActiGraph chief technology officer Jeremy Wyatt expressed similar praise for ActiGraph’s new partner, stating that “Garmin wearables produce high resolution, accurate data streams that are ideal for scientific analysis and can provide additional, novel endpoints to the ActiGraph software platform.”
Garmin International, Inc. is a subsidiary of Garmin Ltd. Garmin is known for developing a variety of products, such as handheld GPS devices and wearable fitness trackers. On the other hand, ActiGraph offers a variety of activity monitors and also software platforms to analyze data collected by such monitors.
Both Garmin and ActiGraph acknowledge the growing importance of wearable devices as potential health and medical tools. By partnering with ActiGraph, Garmin has indicated its interest in the future development of wearable devices with medical applications. Likewise, the partnership allows ActiGraph to utilize Garmin’s experience in developing wearable devices to apply and hone its data monitoring and management systems.
The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). According to an FDA news release, the approved test is the first direct-to-consumer test to report on three specific BRCA1 and BRCA2 breast cancer gene mutations.
According to the news release, BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. Mutations of these genes may interfere with the production or functioning of the proteins and are linked to an increased risk of female breast and ovarian cancers. About 12% of women in the U.S. population will develop breast cancer sometime during their lives. However, according to the National Cancer Institute, a recent large study estimated that about 72% of women who inherit a harmful BRCA1 mutation will develop breast cancer by the age of 80. Similarly, about 69% of women who inherit a harmful BRCA2 mutation will develop breast cancer by age 80. Because mutations of the BRCA1 and BRCA2 genes may be passed down to future generations, genetic testing for breast cancer risk has become more common.
23andMe offers genetic testing directly to consumers. Traditionally, genetic testing was only available through healthcare providers: an individual would request tests from a healthcare provider, the healthcare provider would order tests from a laboratory, collect and send the samples, and interpret the test results before passing them onto the individual. In contrast, direct-to-consumer genetic testing allows consumers to order and perform genetic tests without needing to interact with a healthcare professional. 23andMe has previously offered direct-to-consumer tests for the purposes of discovering an individual’s ancestry. However, this new FDA approval indicates expansion of genetic testing services to other applications.
Although the FDA approval of 23andMe’s test is positive, the FDA expressly noted certain caveats regarding the test. Specifically, the FDA clarified that the test only detects three out of more than 1,000 known BRCA mutations and that only a small percentage of Americans carry one of the three mutations. A negative result therefore does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk. Additionally, the FDA is establishing criteria, called special controls, which set forth the agency’s expectations in assuring the test’s accuracy and performance. Though this test may be a precursor for exciting possibilities on the horizon, the FDA warned that this limited test should not completely replace consultations with a health care professional.
Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to file AKL-T01 with the U.S. Food and Drug Administration (FDA) for clearance under the 510(k) medical device pathway as a novel treatment for children and adolescents with attention deficit/hyperactivity disorder (ADHD).
According to the article, unlike traditional drug treatments for ADHD, AKL-T01, also known as Project: EVO, is a video game patients play on a tablet device. AKL-T01 uses storytelling and reward
mechanisms, like those found in standard video games, and further uses adaptive algorithms to automatically adjust the level of stimulus up or down to target deficient cognitive neural systems in the brain and meet the specific needs of the patient.
The article further notes that in the randomized, controlled trial, 348 children and adolescents diagnosed with ADHD were evaluated before and after four weeks of at-home treatment with either AKL-T01 or an active control. According to Akili’s press release, children and adolescents who used AKL-T01 showed a statistically significant improvement in attentional functional compared to the children in the active control group. According to Akili, a full analysis of the results is underway and will be presented in upcoming peer-reviewed publications, scientific conferences, and medical meetings.
The use of interactive software as digital treatment is a relatively new trend. The FDA recently approved what it characterized as its first-ever mobile medical application, an application developed by Pear Therapeutics to treat substance use disorders. As reported by Reuters, Akili’s plan to file for FDA approval may pave the way for what would be the first such digital prescription product to tackle ADHD. Considering that Pear Therapeutics was recently selected to participate in the FDA’s digital health software precertification pilot program, the FDA has provided an indication that the agency may be interested in the type of digital therapy treatment Akili claims to offer.