A steady procession of mobile health devices continues to march through the FDA's regulatory process.

The US Food and Drug Administration has granted Redmond, Washington-based mobile health start-up Mobisante 510(k) clearance for its smartphone-based ultrasound system, MobiUS.

Dr. Sailesh Chutani, CEO and co-Founder of Mobisante, was previously an executive at Microsoft. Before founding Mobisante in 2007, Chutani created Microsoft's mHealth initiative in 2006, but the group was not called that because the term was not yet widely used. As part of his responsibilities at Microsoft, Chutani managed $100 million of investments in emerging markets for the company.

The mobile ultrasound imaging system will cost between $7,000 and $8,000 in full, which includes a Toshiba Windows Mobile-powered smartphone, an ultrasound probe and the company's software. Mobisante hopes to halve the cost of the system over time, but the pricetag is still much lower than the tens of thousands or in some cases more than $100,000 other ultrasound systems cost today.

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 port for the probe. Given restrictions in processing power a lack of support for USB 2.0, popular devices like Apple's iPhone and devices running on Google's Android OS cannot support MobiUS.

Update: "We need USB 2.0 host support," Chutani told MobiHealthNews in an email. "This allows peripherals such as our ultrasound transducer to connect to the phone and draw power from it. Currently none of Android and iPhone have that support. We are lobbying the OEMs to encourage them to do it. It will make it much easier to develop new medical devices that use the smart phone as a true computing platform. The processing speed with Snapdragon from Qualcomm that runs at GHz is fast enough for what we need."

Mobisante told Xconomy in an interview that MobiUS will work on one of the new tablet devices, the HP Slate.

Mobisante expects MobiUS devices to make their way to rural clinics in the US and other parts of the world with low population density, limited resources or areas that are remote and located far from urban centers. Once the device reaches a lower price point, the company hopes to bring it to emerging markets.

"These systems are affordable enough that each of our clinics in rural eastern Washington could have one, facilities many hours away. Furthermore, since the devices are connected, it is easy to get a second opinion from remote experts," Greg Brandenburg, CEO of Columbia Basin Health Association in Othellow, WA stated in a company release. His clinic tested an early version of the device in a pilot, according to Mobisante.

Late last year Mobisante received an undisclosed seed investment from WRF Capital.

In April 2009 we wrote about a couple of computer engineers at Washington University who had developed a very similar offering to MobiUS: A medical imaging device that consisted of a USB-based ultrasound probe paired with a Windows Mobile smartphone. Microsoft awarded the engineers $100,000 in 2008 to bring the concept to fruition.

Last February perhaps the most high profile handheld ultrasound device to date gained FDA clearance: GE's Vscan. GE describes Vscan as a “pocket-sized visualization tool developed to provide physicians with imaging capabilities at the point-of-care” that is “roughly the size of a smart phone” and includes “ultra-smart ultrasound technology.” But -- it does not currently include any connectivity. No cellular, no WiFi.

GreatConnection is another mobile health startup that is innovating around ultrasounds. The San Diego-based startup enables expecting parents to access and share their ultrasound images with friends and family moments after they see them for the first time themselves. The Mobile Baby service sends ultrasounds (securely) right to patients' smartphones in an easy-to-share format.