regulators

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 … 
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Before the Apple and Beats marriage can really be official, the two companies must first gain regulatory approval from various governing bodies where the companies conduct business. Apple included the following expectation in its official press release announcing the deal: Subject to regulatory approvals, Apple expects the transaction to close in fiscal Q4.

For Apple, having regulatory approval and closing the transaction by the end of fiscal Q4 means it expects everything to be in order by the end of September. According to a Reuters report, regulators in the European Union will announce their decision on the deal by July 30th next month.
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