Medical imaging technology associate company Adaptix has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Digital Tomosynthesis Orthopedic imaging system. This medical imaging product allows for three-dimensional (3D) X-ray imaging of hands, elbows and feet.
It is the company’s first medical imaging product to receive FDA 510(k) clearance.
“We are delighted to receive the 510(k) clearance, which allows this innovative technology, and our first medical product, to be marketed in the world’s largest healthcare market,” said Mark Evans, CEO of Adaptix, in the company’s press release.
“The team are energized by achieving this milestone, and we look forward to delivering enhanced orthopedic DT imaging systems; a dental DT imaging system; and a chest DT imaging system for Intensive Care and Emergency Department use.”
“We see a future where 3D travels to the patient at the point-of-care throughout hospitals, clinics and primary care transforming patient pathways, improving patient experience and reducing the cost of care delivery,” added Evans.
Benefits of Adaptix’s Orthopedic Imaging System
Two-dimensional (2D) X-ray imaging may not provide precise information along the Z-axis of an inspected object, so the depth and location of any inside features of an object cannot be accurately determined.
Adaptix’s new imaging system is portable and provides fast 3D X-ray imaging at the point of care. Therefore, the product provides clearer images than 2D X-ray systems, and that brings numerous benefits such as less acquisitions needed, faster patient workflow and improved diagnostic accuracy.
In addition, the imaging product was designed to operate at a fraction of the radiation dose and per-study price of conventional computerized tomography (CT) systems.
Adaptix already offers services for the veterinary and industrial markets.
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