Mobisante Wins FDA Approval for “Ultrasound on a Smartphone” Technology

Xconomy Seattle — 

Seattle is the global capital of ultrasound technology, and now it can lay its claim as the place that developed the first FDA-cleared system that puts ultrasound on a smartphone.

Redmond, WA-based Mobisante said today it has won FDA clearance to start selling its MobiUS system to healthcare professionals in the U.S. The startup, which began R&D work in 2007, will now race over the next several months to establish manufacturing protocols so it can deliver its new ultrasound imaging system in a way that will pass future FDA audits, says CEO Sailesh Chutani.

The Mobisante ultrasound system will cost between $7,000 to $8,000 for the whole package—a Toshiba TG01 Windows Mobile smartphone, with ultrasound probe, and Mobisante’s proprietary software, Chutani says. The company hopes to cut that price in half over time, and is experimenting with leasing models to bring cost down even further, Chutani says. If that can be done, then Mobisante can start to dream much bigger about getting ultrasound into the hands of healthcare workers in remote villages around the world, doing basic scans for internal bleeding, fetal health, and other common tasks. Such scans can only be done today on ultrasound systems that cost at least $20,000, and often more than $100,000—putting them far out of reach of the average front-line healthcare professional, even in the U.S.

“I’d like for every healthcare worker in the world to be able to have one,” Chutani says.

This company is really a bootstrap kind of story. I wrote about Mobisante back in December, when it raised an undisclosed amount of seed financing from Seattle-based WRF Capital. The company was founded by Chutani, a former senior director in Microsoft’s Windows Mobile group, along with David Zar, an ultrasound researcher who previously worked at Washington University in St. Louis.

Sailesh Chutani

Mobisante’s technology, while still in its infancy, moves the field one step closer to what academics have been dreaming for years—the “ultrasound stethoscope.” The hope is that by putting the high-resolution diagnostic images of ultrasound in a super lightweight, convenient package, healthcare professionals will be able to detect and head off any number of ailments that would otherwise go unnoticed in a routine exam.

To be clear, this is still a long way from the ultrasound stethoscope, and Mobisante has a lot of work ahead of it to achieve the mass adoption Chutani hopes for. The company’s proprietary software for processing ultrasound images currently only runs on the Toshiba TG01 phone, equipped with older-generation Windows Mobile 6.5 software platform, and Qualcomm’s Snapdragon platform for high-speed processing of images, Chutani says. The Mobisante system must have that configuration because it needs a USB port so that ultrasound probes can plug in, and so it can draw enough power to capture those images of what’s going on inside the body. The technology isn’t compatible with all the hottest phones today on the market—Apple’s iPhone, or phones that run Windows Phone 7 or the Google Android operating system. (Although Chutani says the Mobisante software will work on one new tablet computer in the works, HP’s Slate, which will display larger images than the Toshiba device.)

But there are big potential advantages in what Mobisante is doing compared with today’s state-of-the-art in mobile ultrasound. By using smartphone hardware, Mobisante has a lightweight, battery-powered device that can be used in remote rural areas. The smartphone’s cellular capability means that Mobisante—unlike other proprietary ultrasound systems—-can capture images taken by an unskilled health worker, who then can e-mail the file to a more trained radiologist at a hospital for a second opinion, Chutani says. While the Mobisante system doesn’t offer nearly as many capabilities … Next Page »

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