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02-02-2014, 04:04 PM #1
Apple Execs Revealed to have Met with the FDA to Discuss "Mobile Medical Applications"
A recent report revealed that high-ranking Apple executives met with FDA Commissioner Margaret A. Hamburg and others in December over “mobile medical applications,” which strongly hinted that a so-called iWatch with health-centric features is well into development. According to the FDA’s public calendar listing, Apple was represented by SVP of Operations Jeff Williams, VP of Software and Technology Bud Tribble, Michael O’Reilly and government affairs counsel Tim Powderly.
It was previously reported that O’Reilly was hired some time last year in an undisclosed role, though the executives pedigree is in medical devices. Before moving to Apple, O’Reilly held the position of chief medical officer and executive vice president of medical affairs at pulse oximeter firm Masimo Corporation. He currently teaches anesthesiology at the University of Michigan and the University of California, Irvine.
Jeff Shuren, the director of the body’s Center for Devices and Radiological Health and Baku Patel attended the meeting for the FDA. Patel was noted as a “staunch advocate” for patient safety, noting that he drafted the agency’s mobile medical app guidelines. Although the reason for the meeting is unknown, Mark A. McAndrew, who spotted the meeting and is a partner at law firm Taft Stettinius & Hollister which handles health and science issues, stated the high-level meet up was nothing but ordinary. McAndrew speculates that Apple may either be looking for ways to clear regulatory hurdles ahead of the medical device or app launch, or alternatively is trying to push something through the FDA after seeing setbacks.
Most interesting is O’Reilly’s presence at the meeting. Being a fairly recent hire, his attendance suggests at least one topic of discussion was a device capable of reading a user’s pulse rate. Alternatively, it may be possible that Apple has selected O’Reilly to head up the iWatch team.
The Cupertino California company is widely rumored to be developing a smartwatch that some expect will have built-in health monitoring capabilities, along with other on-the-go applications. Most wearable devices on the market act as an accessory and connect with a smartphone or other device. Apple’s solution is thought to work similarly, gather information for specific iPhone or iPad apps, while serving as a remote screen for viewing of emails, messages and other correspondence.
We’ll have to wait and see what comes of the whole ordeal.
Source: FDA, The New York Times via AppleInsider
02-02-2014, 10:17 PM #2
With the tight engineering and slick industrial design of all recent Apple products, I completely expect their watch to look and function beautifully. Even though Samsung and Pebble were the first out of the gate, they'll probably have a lot of catching up to do once the iWatch is released. Assuming it's not just a rumor, of course.