Healcerion said it received the U.S. FDA approval for SONON 300L, a wireless portable ultrasound device on Oct. 13.
The SONON 300 series can be used in a variety of medical applications at medical, education and emergency disaster sites. Its battery-powered power supply system enables ultrasonic examination in the absence of stable electricity supply, and ultrasound signals are transmitted to the smartphone or tablet PC via Wi-Fi and are easy to use even in an emergency situation without a separate connection line, the company said.
It also provides echo imaging, measurement, and analysis of the human body for general clinical applications, including musculoskeletal (MSK), vascular, small parts (breast, thyroid) and lung imaging.
The equipment also offers multi-frequency -- 5, 7.5, and 10MHz -- and has a color mode, which allows users to see the image clearly and in-depth. The machine’s color doppler function is also used to check blood vessel status.
“We expect the device will help accelerate our advance to the U.S. market by acquiring FDA approval,” the company said in a statement.
Healcerion 힐세리온 also has signed a 100 million won ($88,260) contract with the United Nations Office for Project Services (UNOPS), a humanitarian aid organization, to supply wireless ultrasonic diagnostic device to Ghana.
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