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 as the big and expensive machines sold today by General Electric, Philips Healthcare, and Siemens, it’s the kind of thing that a first-responder/EMT can use to get a basic grasp of the problem, and refer patients to a specialty radiologist for more detailed analysis, Chutani says.

Mobisante has its eye on marketing its technology in the U.S. mostly to doctors who don’t have access to ultrasound already—those in rural and community health practices, Chutani says. That’s based on feedback it got from beta users, like Greg Brandenberg, the CEO of Columbia Basin Health Associates in Othello, WA, whose clinics tested an earlier version of the device. Many clinics here in the U.S. can’t afford to pay the $20,000-and-up prices for handheld proprietary ultrasound machines like the ones offered by Bothell, WA-based SonoSite (NASDAQ: SONO).

“These systems are affordable enough that each of our clinics in rural eastern Washington could have one, which means we won’t have to send our patients to facilities many hours away,” Brandenburg said in a Mobisante statement. And, “since the devices are connected, it is easy to get a second opinion from remote experts.”

Over time, Mobisante plans to seek out approval to sell its device in Europe, and in other regions around the world.

Chutani, who’s originally from India, said he’s particularly interested in putting his device in the hands of healthcare workers in Africa and Latin America—where ultrasound has never really become very widespread, usually because of cost. Pilot projects are being set up in the Philippines and Nepal, and Chutani has his sights set on India, too. Before moving ahead too quickly, he wants to make sure cultural sensitivities are respected in certain developing countries, where determining the sex of fetuses can raise problems, when families often want to have boys, not girls.

Those are important questions to ask years from now. For now, Mobisante is in position to start selling in the world’s biggest healthcare market, after passing the technical scrutiny of the world’s toughest health regulatory body. It will now be up to Mobisante to prove to doctors that its machine is good enough to warrant the $7,000 to $8,000 price tag.

If that’s the case, Mobisante will be in position to do more development to keep driving down costs to the point that ultrasound for the masses gets realistic. That is clearly the kind of thing that could resonate in Seattle for a long time, and for a number of reasons.

“Seattle has very deep expertise in ultrasound and very deep expertise in mobile,” Chutani says. “We couldn’t have picked a better place to do this, especially when you start thinking about the global health expertise that’s here, and what our solution can do for maternal and fetal health. We really lucked out.”

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