Mobisante Wins FDA Approval For The World’s First smartphone-­based ultrasound imaging system

Mobisante, Inc., a privately held medical device company located in Redmond, WA, announced recently that it has received 510(k) clearance from the FDA for its smartphone-based ultrasound imaging system, MobiUS.

The world’s first smartphone-based commercial ultrasound system, MobiUS is a mobile ultrasound imaging system that uses a smartphone and internet cloud services. The MobiUS system is indicated for ultrasound imaging, measurement and analysis of the human body for the following clinical applications: fetal/OB, abdominal, cardiac, pelvic, pediatric, musculoskeletal, and peripheral vessel imaging.  Since MobiUS is based on smartphones it can leverage cellular networks or Wi-Fi to send images to a remote expert for diagnosis or a second opinion, or to a Picture Archiving and Communication System (PACS) for storage.

Mobisante CEO Sailesh Cutani says that 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. The company hopes to cut that price in half over time, and is experimenting with leasing models to bring cost down even further.

“MobiUS’s progress is very exciting. Such connecting devices can help save lives, fundamentally redefine health care and open up new revenue streams for the mobile ecosystem, including the mobile operators,” said Chetan Sharma, president of Chetan Sharma Consulting and a recognized expert in the mobile industry.

Mobisante, Inc. is a privately held mHealth product and services company whose goal is to make ultrasound imaging more accessible and affordable to help health care professionals practice better medicine and to reduce costs. The company was recently awarded the Global Mobile Award for the best mhealth innovation and was a presenter at OneMedForum SF 2011.

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