Adaptix, a medical imaging company in the U.K., submitted a 510(k) application to the FDA so it can market its Point-of-Care 3D orthopedic system in the U.S.
The technology is designed to provide affordable, low-dose 3D imaging at the point of care to enable quicker and more accurate diagnoses, the company said in a July 12 news release.
2D X-ray is the most prominent diagnostic modality, but can result in inconclusive reads because clinical interest areas are obscured by overlying and underlying tissues. This leads to diagnostic "misses" and delays, additional referrals for an "over-read," and excessive and expensive escalation to computer tomography or MRI, as well as potentially the unnecessary immobilisation of a limb for a patient waiting for diagnosis, according to Adaptix.
"This is the first of many innovations that Adaptix is excited about bringing to medical markets," Mark Evans, CEO of Adaptix, said in the release. "The U.K. is the country that invented the first clinical CT and MRI scanners, and our new low-cost 3D imaging technology builds on the long-standing U.K. pedigree of innovation in medical imaging."