On April 28, 2023, the Company received clearance from the U.S. Food and Drug Administration (the “FDA”) to market the Nanox.ARC (including the Nanox.CLOUD) as a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers and other medical practices by trained radiographers, radiologists and physicians.
Generated $2.4 million in revenue in the first quarter of 2023 compared to $1.8 million in the first quarter of 2022.
Received ISO 13485 certification for Medical Devices Quality Management Systems for the Company’s Korean fabrication facility, which covers Design, Development, Manufacturing, and Sales of X-Ray Tube for Medical Use, and is valid for a period of three years.
Working to establish a demo center in Fort Lauderdale, Florida for the Nanox.ARC system. We expect to receive an import license during the second quarter of 2023.
On May 19, 2023, we entered into a three-year distribution pre-sale agreement with Vital Tech SARL to deploy 270 Nanox.ARC units in the Kingdom of Morocco. We obtained an import license.
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