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FDA approves Sonic Incytes' portable ultrasound device

Sonic Incytes Medical secures U.S. FDA approval for its Velacur One, a handheld ultrasound elastography device used for diagnostic purposes at the point of care.

FDA grants approval for Sonic Incytes' portable ultrasound system
FDA grants approval for Sonic Incytes' portable ultrasound system

FDA approves Sonic Incytes' portable ultrasound device

Sonic Incytes Medical, a Vancouver-based company founded by Dr. David W. K. Lam and Dr. Jeffrey H. Lau, has announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its point-of-care ultrasound (POCUS) elastography device, Velacur One.

Velacur One is a unique device, designed for ultrasound elastography, that aids in the management of chronic liver disease. The device employs 3D S-WAVE technology for measuring attenuation and liver stiffness, making it particularly useful for managing metabolic dysfunction-associated steatohepatitis.

The FDA's clearance for Velacur One also includes the use of its new AI output measurement, Velacur Determined-Fat Fraction. This measurement is specific to Velacur One and is used for managing not only metabolic dysfunction-associated steatohepatitis but also chronic liver disease.

Sonic Incytes Medical has noted that Velacur One's capabilities extend beyond traditional ultrasound devices. The company believes that the device will play a significant role in the early detection and management of liver diseases, improving patient outcomes and quality of life.

Velacur One's new AI output measurement, Velacur Determined-Fat Fraction, is a significant advancement in the field of liver imaging. It provides a more accurate and precise measurement of liver fat, which is crucial in the management of metabolic dysfunction-associated steatotic liver disease.

The FDA's clearance for Velacur One marks a significant milestone for Sonic Incytes Medical. The device is now cleared for use in the United States, opening up new opportunities for the company and the potential for improved liver health for many Americans.

With the clearance in place, Sonic Incytes Medical is poised to bring Velacur One to medical professionals across the United States. The company is confident that the device will make a meaningful difference in the management of chronic liver disease, particularly metabolic dysfunction-associated steatohepatitis.

In conclusion, the FDA's clearance of Velacur One represents a significant step forward in the fight against chronic liver disease. Sonic Incytes Medical's innovative device, with its advanced AI output measurement, promises to provide healthcare professionals with a powerful tool for early detection and management of liver diseases, ultimately improving patient outcomes.

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