It took more than eight months, but Mobisante’s mobile ultrasound offering is finally on the market in the U.S.
Mobisante won 510(k) clearance from the FDA in February, but it took the intervening months for the Redmond, Wash.-based company to ready its MobiUS device for commercialization here, co-founder and CTO David Zar told MobiHealthNews.
The delay largely concerned the implementation FDA-mandated systems covering quality control, product tracking, potential recalls and software updates, according to Zar. Earlier this year he pegged the cost of the initial clearance process with FDA in the low six figures, the website reported.
The $7,495 system consists of a Toshiba Windows Mobile-powered smartphone, an ultrasound probe and the accompanying software created by Mobisante. The approval covers ultrasound imaging, analysis and measurement in fetal/OB, abdominal, cardiac, pelvic, pediatric, muscoloskeletal and peripheral vessel imaging. It works only with the Windows Mobile 6.5-based Toshiba TG01 smartphone and requires a USB 2.0 port for the probe, because more popular devices like Apple’s (NSDQ:AAPL) iPhone or those running the Android OS made by Google (NSDQ:GOOG) don’t support USB 2.0.
That’s an evident source of frustration for Zar, who cites smartphone and tablet makers and U.S. mobile operators for not creating more devices with USB support.
“I’ve heard it’s because of security concerns or that some user will take down the carrier’s network,” he told MobiHealthNews. “Sounds like an attorney is making that decision, not an engineer.”
Mobisante is looking into a tablet-based solution, prompted by interest from potential customers, Zar told the website.
“These are tablets healthcare professionals have had at the bedside for years,” Zar said. “[MobiUS] would be an added benefit for the platform they already have in place. For many, this is not a replacement system. We can also offer the full imaging solution, though, and that might appeal to smaller clinics. Our work has just begun, really.”