Apple met with FDA regulators to discuss mobile medical applications

BY Kelly Hodgkins

Published 1 Feb 2014

irisscan121613Apple’s been quietly working on health technology, scooping up some the brightest scientists in the field. The company also been meeting with the FDA to talk about mobile medical applications, says a report in the New York Times.

The New York Times was alerted to an FDA calendar with an entry for a meeting with Apple. Food and Drug Commissioner, Margaret Hamburg met with a team from Cupertino that included Apple heavyweights like Jeff Williams, senior vice president of operations Jeff Williams,  vice president of software technology Bud Tribble, government affairs employee Tim Powderly and Michael O’Reilly, who joined Apple last year after serving for five years as Chief Medical Officer at Masimo.

Apple’s meeting with the FDA was likely a serious affair and encompassed more than your typical conversations. Given the high-profile attendees on both sides, Apple was there to talk medical applications in a meaningful way.

“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,” said health and science lawyer Mark A. McAndrew, “or Apple has been trying to push something through the F.D.A. for a while and they’ve had hangups.”

During public appearances and earnings conference calls, Tim Cook has talked about a new category of products that are coming from Apple. Pundits used to believe this new product would be an Apple television, but now the focus has shifted to the iWatch. Rumor upon rumor suggests Apple is going to move beyond a basic fitness tracker and use sensor technology to measure health parameters like blood pressure, glucose levels and more. This also corroborates with the latest rumor, which suggests that Apple is looking to break into the fitness and medical field with the iWatch and a new app called Healthbook in iOS 8.