FDA

Health accessories for iPhones, iPads, and iPods have become more numerous and diverse over the years, evolving from Apple’s early Nike+ run sensors to heart rate monitors, increasingly complex Wi-Fi scales with body fat and ambient room sensors, blood pressure cuff docks… and even Bluetooth toothbrushes. Some health accessories are undeniably useful, but others raise the question “why?” — why pay more to see my weight on an iPhone rather than the scale’s built-in screen? Why track daily tooth brushing, body fat percentages, or the humidity of one’s bathroom? People survived for thousands of years without charting every seemingly minor blip on their personal radars.

My perspective changed last month when my wife was diagnosed with a serious cardiac condition. One of those “seemingly minor blips” that can now be constantly monitored is your heartbeat, and when something’s wrong with your heart, advance knowledge literally makes the difference between living or dying. As it turns out, a San Francisco-based company named AliveCor is now on its third-generation version of an iPhone accessory that helps people with cardiac conditions. The AliveCor Mobile ECG ($75) is an FDA-approved electrocardiogram (ECG) monitor that can record and share your heartbeat directly from your iPhone. Measuring roughly 3.2″ by 1.3″ by 0.2″, Mobile EGC can self-attach to your iPhone’s back, or integrate with a bundled custom iPhone 6/6s case for only $80 (there’s an iPhone 5/5s case, too). Given my family’s sudden need for quick access to ECG data, keeping it with an iPhone makes sense, as this is an accessory we’ll want to have on hand whenever it may be needed…

Expand
Expanding
Close

iFixit’s teardown of the Apple Watch has revealed that the sophisticated heart-rate monitor used is actually capable of acting as a pulse oximeter, allowing it to calculate the oxygen content of your blood by measuring how much infrared light is absorbed. This data would be useful for health and fitness monitoring, but the functionality is not currently enabled in the watch.

As iFixit notes, there are a couple of possible reasons Apple is not currently allowing to watch to display this data … 
Expand
Expanding
Close

While health tech has to be approved by the Food and Drug Administration, the agency will be taking “an almost hands-off approach” to fitness-oriented wearables like the Apple Watch, says policy advisor Bakul Patel in an interview in Bloomberg.

“We are taking a very light touch, an almost hands-off approach,” Patel, the FDA’s associate director for digital health, said in an interview. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”

Patel said the FDA would be drawing a distinction between products whose health claims focused on fitness rather than diagnosis … 
Expand
Expanding
Close

Following Apple employees’ meeting with the FDA to discuss “mobile medical applications” earlier this year, AppleToolbox has published a response from the FDA to a Freedom of Information Act Request asking for more information about what was discussed.

A response to the request took three months to complete, and arrived just after Apple introduced its new HealthKit platform and Health app for iOS 8 last week. While much the FDA’s answer sounds like Apple was discussing HealthKit, the response also gives some interesting clues that Apple is working on health products that go beyond the sensors currently in the iPhone and iPad:

With the potential for more sensors on mobile devices, Apple believes there is the opportunity to do more with devices, and that there may be a moral obligation to do more… Sensors already exist on medical devices. For instance, Apple’s devices have cameras and accelerometers. There is still an opportunity to innovate, but Apple wants to make sure they are on the side of the FDA.

So we can assume Apple was likely meeting with the FDA for HealthKit, which takes advantage of the iPhone’s sensors and data collected by third-party apps through already available accessories, but it was also discussing implications of possibly tapping into additional sensors and doing more in the way of measuring health data. It won’t be any surprise to those that have followed our reports on iWatch as far back as last year, and we’ve continued following as Apple builds a team of medical, fitness, and sensor experts to work on the project.
Expand
Expanding
Close

Apple has added Divya Nag, a rising star in the medical device community, to its in-house medical technology team, according to sources with knowledge of the hire. Nag made her entry into the medical technology world earlier this decade by co-founding Stem Cell Theranostics, a company that focuses on technologies for testing new medicines for the market and how the drugs will affect patients. Nag also participated in the Stanford-based StartX, an “accelerator” for medical technology-focused startups. Nag was just recently recognized for her many accomplishments in the medical and science fields with the Forbes’ annual 30 Under 30 award.

Expand
Expanding
Close

Bloomberg reports the U.S. Food and Drug Administration is launching a first of its kind inquiry into medical diagnosis apps starting with the ‘uChek’ urine analysis app from Biosense Technologies. The free app, which is currently still on the App Store, requires users to purchase a kit containing urine test strips that can be visually analyzed with the iPhone’s camera. The problem, according to a letter sent to Biosense from the FDA, is the fact that the test strips have only been cleared for “direct visual reading” and not automated analysis from an application:

Please note that though the types of urinalysis dipsticks you reference for use with your application are cleared, they are only cleared when interpreted by direct visual reading.  Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader.  When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system.  Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).

While Biosense plans to work with the FDA to resolve the issue, Bloomberg notes that this is only the start of a broader crack down on apps that claim to diagnose medical conditions:
Expand
Expanding
Close