Sonoscanner, a French ultrasound manufacturer, announced the achievement of FDA certification for its new ultrasound device, the U-Lite PRO. The first complete ultraportable ultrasound machine (equipped with all Doppler modes and all probes) to obtain this prestigious certification, the U-Lite PRO also opens up new medical possibilities for numerous specialties.
To develop the U-Lite PRO ultrasound machine, Sonoscanner conducted more than 5 years of R&D in collaboration with renowned expert physicians. The ultrasound device is presented in the form of a specific tablet, promoting mobility, and incorporates numerous innovations, including artificial intelligence, facilitating the use of ultrasound technology for novice physicians.
The U-Lite PRO represents a significant step ahead for three specialties:
- Emergency Medicine: The U-Lite PRO's comprehensive features (transcranial Doppler, continuous Doppler, etc.) combined with its mobility, enable Emergency Services to assess patient health status quickly and accurately in emergency situations or in the field.
- Sports Medicine: With high-definition images, presets developed in collaboration with sports medicine professionals, and its compact format, the U-Lite PRO provides sports doctors with a musculoskeletal image at an athlete’s side, on the field.
- Cardiology: The U-Lite PRO includes all necessary Doppler modes and measurements for cardiology, providing radiologists with a powerful diagnostic tool at all times.
FDA certification is particularly stringent, especially in the field of cybersecurity. Users of the U-Lite PRO, benefit from one of the highest standards of security and quality in the world.
For Sonoscanner, which generates 23% of its revenue in the United States, obtaining this demanding certification will accelerate development on the other side of the Atlantic.
"Receiving FDA certification for the U-Lite PRO is a major milestone for Sonoscanner," declares Etienne Richard, CEO of Sonoscanner. "It demonstrates our commitment to the quality of patient care and the quality of our products. This will enable our numerous American Clients to benefit from our latest innovations."
Sonoscanner continues its international development. The ultrasound system manufactured in France by Sonoscanner contributes to improving healthcare provided by General Practitioners, Emergency Physicians, and other Specialists. It also offers a solution for medical deserts by democratizing access to imaging and telemedicine.
Source: Sonoscanner
