In February Mobisante announced that the FDA had cleared its handheld, smartphone-enabled ultrasound offering, and while the company hoped to launch "a long time ago," MobiUS only just became commercially available in recent days, Mobisante co-founder and CTO David Zar told MobiHealthNews.
Since it received its 510(k) clearance eight months ago, Mobisante has been working to put its quality systems in place along with a number of other FDA mandated controls related to product tracking, potential recalls, software updates and more. Zar said that the process took a lot long than expected. The extra time and additional protocols have helped the company further refine its product, Zar said, so ultimately it's been a good thing.
The initial FDA clearance process cost Mobisante in the low hundreds of thousands of dollars, Zar told attendees at the West Wireless Health Institute's HCI-DC event earlier this year.
The mobile ultrasound imaging system includes a Toshiba Windows Mobile-powered smartphone, an ultrasound probe and the company’s software. Mobisante’s device is intended for ultrasound imaging, analysis and measurement in fetal/OB, abdominal, cardiac, pelvic, pediatric, mucoskeletal, and peripheral vessel imaging. The smartphone-based ultrasound system can leverage both cellular and WiFi to send images for diagnosis, second opinion, or to a Picture Archiving and Communication System (PACS) for storage.
MobiUS only works on the Windows Mobile 6.5-based Toshiba TG01 smartphone and requires a USB 2.0 port for the probe. Because they lack support for USB 2.0, popular devices like Apple’s iPhone and devices running on Google’s Android OS cannot support MobiUS.
Zar said that some of Mobisante's potential clients have asked about support for healthcare specific tablets like those offered by Panasonic's ToughBook division as well as those offered by Motion Computing, so Mobisante is looking into a tablet-based solution for that group.
"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."
Zar is frustrated with smartphone and tablet makers as well as US mobile operators who are not bringing devices to the US market with USB host support. Some phones available in Europe, for example, have full USB support but once the model launches in the US the feature is removed or stripped down.
"I've heard it's because of security concerns or that some user will take down the carrier's network," Zar said. "Sounds like an attorney is making that decision, not an engineer."
Mobisante's MobiUS offering is available now with a starting pricepoint of $7,495, which is comparable to its next closest competitor, GE's Vscan -- a mobile, but not wirelessly connected handheld, ultrasound device.