FDA Lowers Handset Healthcare Hurdles

Market Insight

The US Food and Drug Administration (FDA) recently cleared two handset-based applications for healthcare use. One application includes a specially configured handset as part of the application, while the other is a downloadable iPhone app. Both applications hint at the broad potential for mobile handsets in medical care. The approvals combined with a new, less onerous classification system for medical devices, encompassing mobile handsets, point to the FDA’s efforts to lower the hurdles to bringing mobile technology-based medical devices to market.

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