OXOS Medical Gains FDA Clearance for Micro C in Pediatrics

By Julie A. Vetalice

OXOS Medical Gains FDA Clearance for Micro C in Pediatrics

OXOSⓇ Medical announces that the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the company to market its Micro CⓇ Medical Imaging System, a handheld dynamic digital radiography (DDR) system, for use in pediatric radiography.

Medical x-ray imaging is necessary to accurately diagnose and treat a variety of conditions, but exposure to ionizing radiation must be kept especially low in children. FDA recommends that pediatric medical x-ray imaging exams use the lowest radiation dose necessary and efforts should be made to minimize risk by reducing unnecessary exposure to ionizing radiation, especially in pediatric populations.

Legacy x-ray machines are large, bulky, and generally lead to higher radiation exposures. The fixed geometry of these machines makes it difficult to accurately position and impossible to reduce exposure to the lowest amount when imaging pediatric patients. Radiation doses vary widely, even for the same examinations performed by x-ray machines with similar x-ray detectors. Small shifts can cause drastic changes in the dose delivered to the patient, adding unnecessary risk for vulnerable pediatric patients. The patented Micro C No-Fire positioning system allows operators to safely adjust positioning to capture the exact image without wasted radiation.

“The untethered design of the Micro C allows providers to reduce dose in ways that are simply not possible with other solutions,” explains Evan Ruff, Chief Executive Officer. “Existing machines often expose pediatric patients to 10 times the dose of the Micro C, so we’re very excited to offer this low dose and safe imaging technology to providers nationwide.”

With this latest FDA clearance, OXOS Medical continues on the path to deploying Micro C technology wherever care is needed. OXOS enables anyone anywhere to access radiologic diagnostics at the point of care, expanding availability and changing the way healthcare is delivered.

Source: OXOS Medical

Tags: 510(k) Clearance, Regulatory