Apple Boss Hints at Making a FDA Approved Medical Device But Not in Watch Form

Apple Boss Hints at Making a FDA Approved Medical Device, But Not in Watch Form
November 11, 2015
By Alex Keown, BioSpace.com Breaking News Staff

LONDON – Apple has plans to continue to develop wearable medical devices, but it is unlikely to include the new Apple Watch in that sphere, Apple chief Tim Cook told The Telegraph of London.

One reason the smart watch will not be included in the health sphere is the company does not want the watch to undergo regulatory scrutiny by the U.S. Food and Drug Administration (FDA). Although Cook does not want to see the new watch undergo regulation, he hinted Apple could develop something “adjacent to the watch.”

“We don’t want to put the watch through the Food and Drug Administration (FDA) process. I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it -- maybe an app, maybe something else,” Cook said to the Telegraph.

The Apple Watch is designed in part, with health in mind. The watch measures “all the ways you move, such as walking the dog, taking the stairs, or playing with your kids. It even keeps track of when you stand up and encourages you to keep moving,” according to Apple’s website. In addition to the watch’s design, there are numerous health and fitness applications available for the Apple watch, including the Activity app, which provides a snapshot of daily activity, with three rings telling you everything you need to know. The Stand ring shows how often you’ve stood up to take a break from sitting. The Move ring shows how many active calories you’ve burned. And the Exercise ring shows how many minutes of brisk activity you’ve completed, according to the website.

Wearable technology that collects health and fitness data is an important tool drug companies can tap into as they eye treatments for various diseases. A massive amount of patient data would allow the companies to develop therapies and drugs that target disease at its source, which is part of the push toward precision medicine. The raw data will allow research scientists to study their genetics, environmental information and microbial information to learn how to individualize medical care. Earlier this year, Biogen, Inc. partnered with PatientsLikeMe to explore ways to use wearable activity trackers with multiple sclerosis patients to gather data about patient activity, which will be able to help physicians with treatment options. The majority of MS patients deal with mobility issues.

Apple’s technology has been on the cutting edge of data gathering to develop patient information. In April, Apple unveiled ResearchKit, a software framework designed for medical and health research that helps doctors, scientists and other researchers gather data more frequently and more accurately from participants using mobile devices. The app was met with enthusiasm as more than 60,000 iPhone users signed up with the app. The first research apps developed using ResearchKit study asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease. According to Apple, the open source framework allows any medical researcher to take advantage of the initial modules in ResearchKit to study health and wellness and better understand disease. Developers can also build new modules based on the open source code and contribute them to ResearchKit. The initial customizable modules address the most common elements found in research studies—participant consent, surveys and active tasks.

In July, GlaxoSmithKline and Purdue Pharmaceuticals announced they would be using Apple’s ResearchKit to integrate the information into clinical trials.

In August, fashion designer Ralph Lauren launched a new shirt that combines fashion and technology that will allow wearers to measure their heart rates and calories burned while wearing it. The new PoloTech Smartshirt features sensory receivers woven into the fabric that provides real time data, such as heart rate, stress levels, breathing levels, energy output and more, to allow wearers to maximize their workouts. Additionally, the shirt will record the number of calories burned and the number of steps taken during a workout. Data is collected in a “black box” placed inside a specially designed pocket below the iconic Polo logo and can then stream the feed to a mobile device using an Apple operating system. The shirt’s “black box” that collects and processes the information uses five connectors and contains a 3D accelerometer that captures intensity of movement based on three g-force measurements.

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