Esaote Receives FDA Clearance for Its Portable MyLab Gamma Ultrasound System

Highly portable ultrasound delivers affordable, feature-rich performance for shared service imaging

INDIANAPOLIS--()--Esaote North America announced that its new MyLab Gamma ultrasound system has received 510(k) clearance from the U.S. Food and Drug Administration and is now available for sale in the United States.

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

“Today’s practices are under increasing pressure to deliver quality healthcare at an affordable cost,” said Larry Dentice, president and general manager of Esaote North America. “The portability and affordability of MyLab Gamma helps providers deliver excellent care wherever and whenever it’s needed."

MyLab Gamma incorporates advanced clinical technologies to support comprehensive cardiac and vascular exams, including TEE, strain, stress echo and other quantitative studies. With 3D/4D capability and a wide range of available probes, the system is also well suited to women’s health, general imaging, and non-traditional point-of-care applications.

Ergonomically designed to be easy to use and reduce sonographer stress, MyLab Gamma can operate on battery power with fast boot times and rapid resume modes so it’s easy to transport and ready to use within seconds. The two onboard probe connectors can be expanded to four, with the optional cart, giving MyLab Gamma users access to a wide range of clinical utility and flexibility.

MyLab Gamma, with its wireless connectivity, remote service capabilities, and three-year warranty, is another innovative clinical solution from prevention to therapy available from Esaote for medical practitioners across the U.S.

About Esaote North America, Inc.

Esaote North America, headquartered in Indianapolis, Indiana, is a leading provider of multi-disciplinary ultrasound and musculoskeletal MRI systems in the U.S. Established in 1979, Esaote North America is part of Esaote Group, a global leader in the research, production and marketing of diagnostic medical equipment. Esaote is among the largest manufacturers of ultrasound systems worldwide and prides itself on achieving superior price-performance over competitors through its focus on only ultrasound and musculoskeletal MRI. For more information, visit www.esaoteusa.com.

MyLab is a registered trademark of Esaote SpA

Contacts

Esaote North America
Gitte Andreasen, 602-316-2429
gandreasen@esaoteusa.com

Release Summary

Esaote North America announced today that its new MyLab Gamma laptop-sized ultrasound system has received 510(k) clearance from the FDA and is now available for sale throughout the USA.

Contacts

Esaote North America
Gitte Andreasen, 602-316-2429
gandreasen@esaoteusa.com