Eight months and several hurdles after receiving 510(k) clearance, mobile-health company Mobisante says its smartphone ultrasound device is officially on the market.
The U.S. Food and Drug Administration clearance alone took so long that the MobiUS system--intended to be used in fetal, abdominal, cardiac, pelvic, and peripheral vessel imaging--only works with the 2-year-old Windows Mobile 6.5-based Toshiba TG01 smartphone and requires a USB 2.0 port for the probe. In other words, it won't be compatible with iPhones and Android-based phones, which don't support USB 2.0.
Still, the device, which, at $7,495, is comparable to its main competitor, GE's Vscan, pushes the envelope for ultrasound systems, which can cost upward of $100,000. (GE's solution is also mobile, but it does not use a wirelessly connected handheld device.)
Mobisante co-founder David Zar tells MobiHealthNews that the MobiUS, which is 5.1 inches by 2.75 inches and weighs just over 11 ounces, isn't necessarily a replacement for most systems. But for smaller clinics, the full imaging solution might make ultrasound systems far more affordable.
Now that the system is finally hitting the shelves, Zar says the company is looking to update device compatibility with a tablet-based solution. "Our work has just begun, really," he says.