FDA approves two 'firsts': Mobisante, Mobile MIM

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Mobisante’s pricing is now pegged at $7-8,000 for a package that includes the smartphone–the Toshiba TG1 Windows Mobile–with the ultrasound probe and proprietary software, with plans to bring the pricing even lower. One wrinkle is smartphone compatibility: the probe needs a USB 2.0 connector which iPhone and Android phones do not have at present, and runs on the older-generation Windows Mobile 6.5 software platform with Qualcomm’s Snapdragon for high-speed processing of images. Its market will be emergency medical techs, smaller clinics and rural healthcare which need the ‘first take’ capabilities at an affordable price. Truly a ‘bootstrap’ story– they only gained seed capital in December. (Remember GE’s Vscan [TA 2 July]? It won approval exactly one year ago, but it has no connectivity; one suspects it’s destined for developing countries.) More details at Xconomy, Mobihealthnews

Mobile MIM started as a showcased app at the debut of the Apple AppStore in 2008, then was pulled shortly thereafter due to regulatory concerns. It became sort of a poster child of the ‘FDA fog’ over smartphones and apps [TA 14 Apr, 31 Mar]. Over two years and two rejected 510(k) applications later, they won clearance today (Friday). It’s approved for the iPhone and iPad, and intended for radiologists who cannot make it to a workstation. Could this mean that FDA is catching up to the mobile world? Dotmednews. FDA release  And a well-written article in the LA Times!