Food and Drug Administration November 10

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In a wide-ranging interview with the Telegraph, Apple CEO Tim Cook has hinted that the company may launch more health-focused products in future – but will keep those separate from the Apple Watch. The reason, he says, is that the FDA approval needed for full-on health devices would slow down the pace of innovation of the Watch.

Cook hints that Apple may have more plans for the health sphere, in a revelation which will intrigue Wall Street, but he doesn’t want the watch itself to become a regulated, government-licensed health product. “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.” 

This represents a significant change from expectations …

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Food and Drug Administration April 24

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 full story

Food and Drug Administration March 30

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 full story


Food and Drug Administration February 9

Diabetics using a glucose monitor made by DexCom will be able to see a continuous graph of their blood sugar levels on the Apple Watch, says the company. It is working on an app for the smartwatch that is expected to be available when the Apple Watch launches in April – alongside a similar app for the iPhone.

DexCom’s glucose monitor tracks a person’s blood-sugar levels continuously. The [app] converts that data into a simple graph that is just a glance at the wrist away.

The WSJ reports that the early availability of the app has been made possible thanks to the Food and Drug Administration taking a more hands-off approach as of last month. While medical hardware still requires FDA approval before it can be sold, companion apps no longer need prior approval – developers simply have to notify the FDA that the app exists …  expand full story

Food and Drug Administration June 9, 2014

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 full story

Food and Drug Administration March 6, 2014

A prototype iPhone case tested by Engadget aims to provide a comprehensive array of vital signs, encompassing heart-rate, blood pressure, temperature, oxygen saturation & lung function.

Readings are done with your hands in a comfortable position, and the health tracker was able to return our vital signs as well as a fancy ECG graph of our heart in just a few seconds. Out of the box, you’ll be able to pair it with your Wi-Fi scale and fitness tracker, so you can keep an overall picture of your health in the same place …  expand full story


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