OXOSⓇ Medical (OXOS) 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. Medical imaging and diagnosis have been complicated and costly, with legacy x-ray machines requiring expensive lead-lined facilities and specialized personnel, limiting access and increasing costs. The Micro C combines a handheld emitter, high sensitivity x-ray detector, and OXOS’ patented positioning system designed to deliver imaging with greater accuracy, clarity, safety, and speed. With the Micro C, practitioners can build their practices, increase patient satisfaction, and democratize healthcare access for all communities.
“Expanding access to radiographic imaging is our mission,” notes Evan Ruff, Chief Executive Officer and Co-Founder of OXOS Medical. “Micro C’s low radiation profile allows the system to provide diagnostic imaging where it’s needed at the exact moment it is needed. We’ve already seen a growing interest to deploy the Micro C beyond the traditional hospital and ambulatory surgery center (ASC) markets—settings such as primary care clinics, emergency departments, urgent care centers, mobile imaging services, cadaver labs, retirement homes, skilled nursing facilities, sports medicine practices, athletic facilities, military deployments, correctional facilities, home health, and rural medicine.”
Expansion of virtual-care and reimbursement during the pandemic has been a catalyst for new healthcare delivery opportunities that will benefit companies like OXOS with systems that support lower-cost, more efficient distributed care scenarios. OXOS anticipates reimbursement opportunities for imaging to continue to grow within the $40 billion U.S. diagnostic radiology market.
“The OXOS mission is to enable anyone anywhere to access radiographic diagnostics at the point-of-care, expanding availability and changing the way medicine is delivered,” stated Dr. Gregory Kolovich, orthopedic surgeon, Chief Medical Officer and Co-Founder of OXOS Medical. “As we continue to develop and launch additional cloud-connected OXOS products, the OXOS Platform—a system for on-demand image management, telehealth collaboration, and delivery of artificial intelligence (AI) diagnostics among other workloads that are currently under development—will bring us closer to achieving our overall mission.”