If that makes any sense to you, well done. If not, don’t worry, that’s what we’re here for. Earlier this week, Verily, a Google/Alphabet company, announced their Study Watch received FDA 510(k) clearance “as a Class II medical device for its on-demand ECG feature. Specifically, the FDA-cleared Study Watch as a prescription-only device intended to record, store, transfer and display single-channel ECG rhythms, and is indicated for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.” According to Verily, “Study Watch has been used by thousands of participants in clinical research studies run by Verily and through our partners, such as the Project Baseline study, Aurora study, Personalized Parkinson’s Project study, and Parkinson’s Progression Markers Initiative.” This is big step and look kids, Big Ben, Parliament.
We recently read one of the better reports on the use of digital technologies in the world of clinical development. Why is it better? Because Deloitte provides some actual case studies/ use cases for these technologies. In one example, a service provider, Science 37, used telemedicine to conduct a complete virtual Phase II study. We have no idea whether the trial will be part of an FDA submission, but cool nonetheless. Another interesting idea from Deloitte is using “Synthetic trial arms or master protocols to reduce the number of patients required to test investigational treatments. A synthetic trial arm uses data from previously completed trials or real-world evidence and is particularly useful in rare disease trials or when a placebo approach is not appropriate or ethical, as is often the case in oncology.” Love it. Speaking of synthetic, here’s a list of the worst synthetic fabrics to wear.
There have been rumblings for a while now that Amazon would somehow be entering the healthcare space to shake things up. Well last week Amazon officially made its move, bringing heavy hitters Berkshire Hathaway and JP Morgan Chase along too. What do two of the world’s richest people and the leader of the US’s largest bank plan on doing exactly? That’s a great question, and we’d love to tell you if there were any kind of concrete details to explain the venture. We do know the goal is to “improve US employee satisfaction while reducing overall costs,” and that they plan to use technology to do it. Sounds vague, but the news was scary enough for investors sent insurer and drug store stocks tumbling after the announcement.
Power issues notwithstanding, the Consumer Electronics Show is typically a good look each year at how wild tech companies are willing to get to come up with the next big thing. This year, health and wellness gadgets took their own share of the spotlight. Starting on the small side, L’Oréal announced a UV sticker you can plop on your nail to make sure you’re not getting too much sun on your beach trip. If you’re more of a homebody, you might be interested in LG’s smart fridge which features a 29-inch touchscreen, an app, and integration with Amazon’s Alexa service. You can even get your own smart sh*thole this year! (Hey, every other news org is saying it this week.) Check out CNET’s roundup of other health gadgets here.
While we’re not quite to the level of checking with Siri on fertility, if you’re curious what your daily likelihood of pregnancy is—you guessed it—there’s an app for that. Natural Cycles, an app that’s recently been certified as a method of birth control by the EU, tracks daily fertility using a highly accurate thermometer to register body temperature combined with details on menstruation to suggest chance of pregnancy on any given day. The app is the first of its kind to receive approval from a European health agency as a legitimate contraceptive and is an updated version of tracking fertility through a calendar. While conventional birth control is still more effective, the app does offer a natural alternative to better plan for or avoid pregnancy.
In the age of Amazon Prime, grocery delivery, and, yep, even sock delivery subscriptions, it’s getting easier and easier to never leave the house. And it’s even more annoying when you do have to venture out and interact with other human beings, amirite? Luckily for us hermits, PAREXEL and Sanofi aim to make it easier to participate in clinical trials from the comfort of your Lazy Boy. The two companies are launching a pilot study to test the medical and scientific viability of wearable devices in clinical trials using PAREXEL’s patient sensor solution. The goals are to make things easier on patients and sites, collect a whole bunch of data, and reduce costs all the way around. High five for progress!
People with Type 1 diabetes could soon be saying goodbye to sticking their fingers to check blood sugar levels. This news comes from a study among children with Type 1 diabetes conducted by the University of Virginia, that tested how well an artificial pancreas developed by the school performed at managing insulin and glucose levels against the patient’s home routine. The platform, which is controlled using a smartphone, uses algorithms that wirelessly link to a blood-sugar monitor and insulin pump worn by the patient, as well as to a remote-monitoring site. The children using the device averaged more time within the target blood-sugar range without an increase in hypoglycemia than those without. Also, probably no need to worry about getting kids to check their phones.
A secret team at Apple, made up of around 30 tech and biomedical experts, is working on a program that would use the Apple Watch as a sensor “that can noninvasively and continuously monitor blood sugar levels to better treat diabetes,” according to three bean-spillers close to the project. This was envisioned by Apple co-founder Steve Jobs prior to his death. The project has been ongoing for at least five years, and is reportedly run now by Apple’s SVP of hardware technologies, Johny Srouji. How would something like this work? Good question. According to a CNBC article, the program would “[shine] a light through the skin to measure indications of glucose.” It’s like something Q would create – for a diabetic 007.