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FDA commissioner met with Apple, others over medical apps

updated 08:00 pm EST, Fri January 31, 2014

Comes on heels of Apple hiring spree for medical, wearable experts

Following the news that Apple had hired Michael O'Reilly, a former chief medical officer at a pulse oximeter company to an undisclosed job position last summer -- and has been steadily poaching or hiring other medical and wearable device experts -- federal meeting logs show that an FDA commissioner met with Apple executives and others in December to discuss mobile medical apps. The meeting's contents were not divulged.

speculative iWatch mockup
speculative iWatch mockup

Among those attending the meeting were FDA Commissioner Margaret Hamburg, along with Reilly, Apple's SVP of Operations Jeff Williams, veteran VP of Software and Technology Bud Tribble and Governmental Affairs Counsel Tim Powderly. The lawyer's presence at the meeting suggests that the discussion may have centered around current medical device regulations or regulatory obstacles. Some have speculated that Apple was either briefing the FDA on a forthcoming medical device, or seeking help with getting such a device through the approval process.

The iPhone maker has been rumored for some time to be working on an "iWatch" that would go beyond typical "smartwatches" with a more-advanced health and fitness component -- essentially combining today's current fitness bands and smartwatches into a superior device, much as it did with the iPhone and iPad. The availability of both Bluetooth Low Energy and Apple's power-efficient M7 co-processor -- perhaps combined with Reilly's expertise in medical apps -- could easily create a device that encompassed a wide range of functionality.

Also present at the meeting was FDA Director for Devices and Radiological Health Jeff Shuren, and the agency's patient rights and safety representative, Bakul Patel. It's possible that the Apple representatives were there to show off an "iWatch" prototype and get feedback on its progress.

by MacNN Staff



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