FDA Clears Emerging LU800 Handheld Ultrasound Device

The Food and Drug Administration (FDA) has granted 510(k) clearance for the ASUS Handheld Ultrasound LU800, which reportedly offers a variety of key attributes and a compact design geared to point-of-care ultrasound (POCUS) versatility in multiple clinical settings.

The LU800 device provides clinicians with five imaging modes and a 128-channel beamformer that facilitates rapid measurements and high-quality imaging, according to ASUS, the manufacturer of the ASUS Handheld Ultrasound LU800.

ASUS said the lightweight wireless ultrasound device can be utilized in a variety of settings, ranging from rural clinics and ambulances to emergency rooms. The company also emphasized that the POCUS device is the first handheld ultrasound with support across the Android, Windows, iOS and Chrome operating systems.

“By integrating AI algorithms, wireless communication technology, medical imaging, and system integration capabilities, we are committed to developing real-time, high-quality, and easy-to-deploy medical imaging tools that empower physicians and health-care teams to enhance diagnostic efficiency and patient care quality,” noted Joe Hsieh, the chief operating officer of ASUS.