After more than eight months of working its way through the red tape, Mobisante’s mobile ultrasound has finally hit the US market.
Since receiving 510(k) clearance from the FDA in February, Mobisante has been working to prepare the mobile device for commercialization in the US. According to David Zar, the company’s CTO, the cost for achieving this initial clearance was in the low hundreds of thousands of dollars. Additionally, in order to accomplish this, Mobisante had to put into action FDA-mandated systems for quality control, potential recalls or software updates, and product tracking.
However, despite the long journey, Mobisante’s mobile ultrasound has finally arrived in the mHealth market place as a $7,495 system. Including an ultrasound probe and Mobisante’s software, the system functions on a Windows Mobile 6.5-based Toshiba TG01 smartphone. Unfortunately, the system can only function on this mobile device due to the fact that most other devices, including the iPhone and Android, do not support USB 2.0, which is necessary to accommodate the probe.
Although Zar is frustrated by this limitation, the product has a wide range of functions that makes up for its limited compatibility with the mobile devices that are currently on the market. So far, the FDA has approved the device for usage in ultrasound imaging, measurement, and analysis of abdominal, cardiac, fetal/OB, musculoskeletal, pediatric, pelvic, and peripheral vessel imaging.
As Mobisante considers branching out into the tablet market in the future, Zar claims, “Our work has really just begun.”