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For medical devices that are based on modern mobile platforms, the average FDA clearance time is down to 67 days. It's not nearly as capital-intensive as it used to be and there are going to be plenty of predicate devices to base your filings on.

The ubiquitous computing plus sensor environment is making healthcare hardware startups the norm—we're seeing more and more applicants in this space at Rock Health. We don't think the FDA process is that onerous, and just published a report outlining the process for entrepreneurs who are new to the space.