USA – The US Food and Drug Administration has approved Vuze Medical’s image processing software, which aids surgeons during spinal procedures, the company has announced.
The Vuze System, a software-only cross-sectional image guidance and verification tool used during surgery, has received 510(k) clearance.
The system employs simple anteroposterior X-rays, as well as cross-sectional images from preoperative CT scans, to provide surgeons with a real-time graphical overlay.
The US Food and Drug Administration has approved Vuze Medical’s image processing software, which aids surgeons during spinal procedures, the company announced recently.
“Our early experience has demonstrated very high surgical accuracy and the Vuze System is proving to be extremely useful,” Ory Keyman, MD, with the Rambam Medical Center in Israel, said in a statement.
“Furthermore, we believe that the Vuze System will enable us to perform a broader range of surgeries in a minimally-invasive manner.”
Keyman was among the first to use the tool successfully during minimally invasive spinal surgeries.
The system does not require sensors, cameras, or additional surgical site calibrations. Furthermore, according to the announcement, the system does not require any add-ons or modifications to be used in conjunction with most standard surgical tools or implants.
Vuze Medical is a privately held medical technology company that specializes in guiding surgeons through common spinal procedures.
Earlier in December, the FDA approved Koios Medical AI software that helps diagnose breast and thyroid cancers.
The AI software, which was developed using data from 48 networks around the world, is said to improve the overall accuracy, consistency, and efficiency of physicians’ breast and thyroid cancer diagnoses.
Every year, approximately 375,000 people are diagnosed with such cancers using ultrasound alone. In order to rule out malignancy, initial imaging results are frequently followed by invasive biopsies.
Koios Medical hopes that their decision support software will help reduce the number of unnecessary procedures by improving physician accuracy and decreasing false positives.
The software is said to improve detection of thyroid cancer by 14% while decreasing false positives by 35%. According to the statement, it also cuts the time it takes to interpret exams by 24%.
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