FDA clears smartphone-based ultrasound

Mobisante has received 510(k) clearance from the FDA for MobiUS, its smartphone-based ultrasound imaging system.

The system uses a smartphone and internet cloud services, and 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, according to Redmond, Wash.-based Mobisante. The system can leverage cellular networks or wi-fi to send images to a remote expert for diagnosis or second opinion, or to PACS for storage.

Mobisante is a privately held mHealth product and services company.

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