A steady procession of mobile health devices continues to march through the FDA’s regulatory process.
The US Food and Drug Administration has granted Redmond, Washington-based mobile health start-up Mobisante 510(k) clearance for its smartphone-based ultrasound system, MobiUS.
Dr. Sailesh Chutani, CEO and co-Founder of Mobisante, was previously an executive at Microsoft. Before founding Mobisante in 2007, Chutani created Microsoft’s mHealth initiative in 2006, but the group was not called that because the term was not yet widely used. As part of his responsibilities at Microsoft, Chutani managed $100 million of investments in emerging markets for the company.
The mobile ultrasound imaging system will cost between $7,000 and $8,000 in full, which includes a Toshiba Windows Mobile-powered smartphone, an ultrasound probe and the company’s software. Mobisante hopes to halve the cost of the system over time, but the pricetag is still much lower than the tens of thousands or in some cases more than $100,000 other ultrasound systems cost today.
Mobisante’s device is intended for ultrasound imaging, analysis and measurement in fetal/OB, abdominal, cardiac, pelvic, pediatric, mucoskeletal, and peripheral vessel imaging. The smartphone-based ultrasound system can leverage both cellular and WiFi to send images for diagnosis, second opinion, or to a Picture Archiving and Communication System (PACS) for storage. Keep reading>>