Monday, February 3, 2014

Apple Executives Met With F.D.A. to Discuss Mobile Medical Applications

According to a public Food and Drug Administration calendar, Apple executives met with medical device and app regulatory officials in mid-December.According to a public Food and Drug Administration calendar, Apple executives met with medical device and app regulatory officials in mid-December.
Apple has signaled strong interest in health-monitoring technology, which could wind up in a widely anticipated smartwatch.
A group of senior Apple executives met with directors at the United States Food and Drug Administration in December to discuss mobile medical applications, according to the F.D.A.’s public calendars that list participants of meetings.
Among the participants from Apple were Jeff Williams, senior vice president of operations; Bud Tribble, vice president of software technology at Apple; Michael O’Reilly, who joined Apple last year; and an employee from Apple’s government affairs department.
On the F.D.A. side of the table were Jeff Shuren, the director of the agency’s Center for Devices and Radiological Health, and Bakul Patel, who drafted the F.D.A.’s mobile medical app guidance and is a staunch advocate for patient safety when it comes to apps and medical gadgets.
Mark A. McAndrew, a partner with the law firm Taft Stettinius & Hollister, which works with health and science clients, first noticed the F.D.A. meeting while browsing the public calendars.
He said in a phone interview that given the prominence of the people in the meeting from both the government and Apple side, these were not your run-of-the-mill conversations.
“They are either trying to get the lay of the land for regulatory pathways with medical devices and apps and this was an initial meeting,” Mr. McAndrew said, “or Apple has been trying to push something through the F.D.A. for a while and they’ve had hangups.”
Steve Dowling, an Apple spokesman, declined to comment. Representatives from the F.D.A. did not immediately respond to a request for comment about the meetings.
Bob Mansfield, Apple’s senior vice president for technologies, who previously ran hardware engineering, has been heavily involved in exploring devices, sensors and technologies within Apple that can monitor people’s health and connect to an iPhone, according to an Apple employee who is not authorized to speak publicly for the company. Mr. Mansfield is directly involved in the Apple smartwatch hardware, this person said.
Timothy D. Cook, Apple’s chief, has been promising new categories of gadgets from Apple for two years.Jim Wilson/The New York TimesTimothy D. Cook, Apple’s chief, has been promising new categories of gadgets from Apple for two years.
Another employee who asked not to be named said that Kevin Lynch, the former Adobe executive who joined Apple last year, was involved in developing software for the watch.
As The New York Times first reported last year, Apple has been working on a curved-glass smartwatch that would connect to a smartphone. The smartwatch will run a variation of Apple iOS and could include apps. Apple is expected to announce the watch this year.
It is widely expected that the watch will have a focus on health monitoring. Apple last year hired several people with expertise in medical sensors, including Mr. O’Reilly, the former chief medical officer of Masimo Corporation, which makes medical monitoring devices.
Last month employees from Google also met with the F.D.A. to discuss possible medical devices, according to Bloomberg. In a blog post on the company’s website, Google said it had been working on a contact lens that can monitor glucose levels for people with diabetes.
Timothy D. Cook, Apple’s chief executive, has been promising a new category of product from Apple since early 2012. This week he reiterated that new gadgets are coming soon from the company.
Given the amount of work going on inside Apple, and the meetings with high-level government officials, it’s possible that Apple could be working on other gadgets beyond the smartwatch that focus on health care, which is a $1.6 trillion industry, according to the United States Census Bureau estimates. Apple’s iPhones and iPads have also supported applications used by medical professionals for several years.

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