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

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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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