Worlds First Smartphone Based Ultrasound Imaging System Cleared by the FDA

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

MobiUS is an innovative mobile, affordable, and accessible ultrasound imaging system that uses a smart-phone and Internet cloud services based commercial ultrasound system.

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. Its compact size, portability and user interface enable it for use in primary and specialty care. Since MobiUS is based on smartphones it can leverage cellular networks or Wi‐Fi to send images to a remote expert for diagnosis or second opinion, or to a Picture Archiving and Communication System (PACS) for storage.

“Meeting the FDA’s of review is a critical milestone for Mobisante. We will now focus on launching MobiUS in selected markets and pursuing the CE mark in Europe”, said Dr. Salesh Chutan, CEO and co-founder of Mobisante.

MobiUS puts ultrasound capabilities into the hands of healthcare providers everywhere. This immediate access is especially important in rural communities in the U.S.A. and abroad that have limited resources, low population density, or are located far from the urban centers.