Esaote’s MyLab Gamma ultrasound system secures FDA 510(k) clearance

2 October 2014 (Last Updated October 2nd, 2014 18:30)

Multi-disciplinary ultrasound and musculoskeletal MRI systems provider Esaote North America has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new MyLab Gamma ultrasound system.

Multi-disciplinary ultrasound and musculoskeletal MRI systems provider Esaote North America has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new MyLab Gamma ultrasound system.

The company announced that the ultrasound system is now available for sale in the US.

MyLab Gamma is a laptop-sized ultrasound system that incorporates feature-rich applications to facilitate its use in a range of clinical environments, from shared service to dedicated clinics and point-of-care.

The system with lightweight portability includes advanced clinical technologies to support comprehensive cardiac and vascular exams, including TEE, strain, stress echo and other quantitative studies.

"The portability and affordability of MyLab Gamma helps providers deliver care wherever and whenever it's needed.."

Esaote North America president and general manager Larry Dentice said: "Today's practices are under increasing pressure to deliver quality healthcare at an affordable cost.

"The portability and affordability of MyLab Gamma helps providers deliver excellent care wherever and whenever it's needed."

Equipped with 3D/4D capability and a wide range of available probes, MyLab Gamma is also well suited to women's health, general imaging and non-traditional point-of-care applications.

Designed to be easy-to-use and reduce sonographer stress, the system can be operated on battery power with fast boot times and rapid resume modes.

Users of the MyLab Gamma system will have access to a wide range of clinical utility and flexibility, as its two on-board probe connectors can be expanded to four, with the optional cart.

The company claims that the easy to transport system, which has wireless connectivity, remote service capabilities and three-year warranty, is ready to use within seconds.