Great question, Tito! Health tech is such an interesting and dynamic area, as it deals with quite different groups: consumers and regulatory agencies like the FDA.
I'm afraid I don't personally have insight into what the regulations mean for startups or large companies, but I would love to hear from those who've been in the field for a while. (Seasoned pros, please comment!)
There is an upcoming meeting (and webcast) focusing on the recent FDA guidelines. Should be worth a listen:
Subject: Wireless Health Group Announcement – FDA Public Workshop on Mobile Medical Applications Draft Guidance
The United States Food and Drug Administration (FDA) is holding a Public Workshop for their Mobile Medical Applications Draft Guidance on Sep 12-13 in Silver Spring, MD, USA (The meeting will be webcasted.)
Complete details can be found here: