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FDA clears Perception ultrasound unit
Perception Ultrasound of Miami has received 510(k) clearance from the Food and Drug Administration for its Perception 5000 PC-based ultrasound scanner, which is based on Windows NT and uses software rather than hardware to control system parameters. The
Perception Ultrasound of Miami has received 510(k) clearance from the Food and Drug Administration for its Perception 5000 PC-based ultrasound scanner, which is based on Windows NT and uses software rather than hardware to control system parameters. The system will be targeted at ob/gyn, vascular, urology, family practice, and emergency room applications. It will carry an average selling price of $40,000 and will be sold in the U.S. through direct sales and dealers.
Perception 5000 is the first Perception scanner to receive 510(k) clearance. Other systems include the Perception 2500, a portable scanner for which 510(k) clearance is pending, and Bak-Pac, a portable battery-powered system under development that will be sold to the military.
Study Reaffirms Low Risk for csPCa with Biopsy Omission After Negative Prostate MRI
December 19th 2024In a new study involving nearly 600 biopsy-naïve men, researchers found that only 4 percent of those with negative prostate MRI had clinically significant prostate cancer after three years of active monitoring.
Study Examines Impact of Deep Learning on Fast MRI Protocols for Knee Pain
December 17th 2024Ten-minute and five-minute knee MRI exams with compressed sequences facilitated by deep learning offered nearly equivalent sensitivity and specificity as an 18-minute conventional MRI knee exam, according to research presented recently at the RSNA conference.
Can Radiomics Bolster Low-Dose CT Prognostic Assessment for High-Risk Lung Adenocarcinoma?
December 16th 2024A CT-based radiomic model offered over 10 percent higher specificity and positive predictive value for high-risk lung adenocarcinoma in comparison to a radiographic model, according to external validation testing in a recent study.
