FDA approves smartphone-based ultrasound system from Mobisante

Physicians are one step closer to a closely held dream: To have a lightweight, portable, high-resolution ultrasound device they can take to patients, rather than having patients come to an ultrasound machine.

Seattle-based Mobisante won approval last week from the Food and Drug Administration for its MobiUS device, which runs on a smartphone platform and allows for capture and email of remote ultrasound images, company execs say. The system isn't yet in production, but should begin manufacturing in the first half of this year, CEO Sailesh Chutani told Xconomy.

The product itself has a ways to go to catch up with the mobile health market, as well. The software only runs on one device, Toshiba TG01 Windows Mobile, and isn't enabled for the big players--iPhone, Android or Blackberry--former Microsoft Mobile exec Chutani admits.

But its price point is certainly right--$7,000 to $8,000 and falling--which makes it far and away more appealing than the five- to six-digit price tags on in-office systems. Chutani told Xconomy that he hopes to ultimately bring the cost down to between $3,500 and $4,000. "I'd like for every healthcare worker in the world to be able to have one," he declares.

"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," beta tester Greg Brandenburg, CEO of Columbia Basin Health Association in Othello, Wash., clinics said in a Mobisante release.

The device attaches via USB port to a smartphone, and can scan for fetal, cardiac, pelvic, musculoskeletal and other abnormalities, according to the company.

The four-year-old company cleared one major financial hurdle in December when it secured an undisclosed amount of investment capital from WRF Capital, also of Seattle. Pundits so far are optimistic that the device will have a market and customers waiting when the product is ready to ship.

To learn more:
- here's Mobisante's press release
- check out this engadget article
- read this Xconomy piece