As the end of the year closes in, vendors find themselves trailing far behind the previous year in the number of devices cleared by the FDA for marketing in the U.S.
As the end of the year closes in, vendors find themselves trailing far behind the previous year in the number of devices cleared by the FDA for marketing in the U.S.
As of Sept. 30, vendors had gained FDA clearances on 211 radiological devices compared with 255 in the year-earlier period. Not since 2002, when the FDA had cleared only 202 devices in the first three quarters of the year, has the number been lower.
This year started slowly, as vendors in the first quarter cleared fewer imaging devices than during any other quarter in the seven years during which DI SCAN has tracked them. In the first quarter 2007, just 55 devices won 510(k) clearances.
Vendors will need a big finish this year, in the neighborhood of 150 clearances, if they are to approach last year's final tally of 360. In the meantime, several notable devices are among those recently cleared.
A digital radiography system, EOS, from French developer Biospace med, incorporates two sets of xenon gas-filled digital detectors and x-ray tubes operating singly or together. The system generates frontal and lateral images of the patient either standing or sitting. EOS is not designed for the evaluation of lung nodules or use in fluoroscopy, angiography, or mammography.
A general-purpose ultrasound system from Chinese manufacturer Shenzhen Mindray can handle freehand 3D imaging and panoramic scans. The new product, DC-6, uses linear, phased, and convex array transducers with a frequency range of 2 to 12 MHz.
Riverain's FirstView is a dedicated server for managing chest radiographs and computer- aided detection results. The workstation acts as an interface with the CAD component, if installed or available at the clinical site, and displays information contained within the DICOM header of the images.
Hitachi's ECLOS CT system collects up to 16 slices of data per rotation operating in a helical scan mode.
The Reading Room: Racial and Ethnic Minorities, Cancer Screenings, and COVID-19
November 3rd 2020In this podcast episode, Dr. Shalom Kalnicki, from Montefiore and Albert Einstein College of Medicine, discusses the disparities minority patients face with cancer screenings and what can be done to increase access during the pandemic.
What is the Best Use of AI in CT Lung Cancer Screening?
April 18th 2025In comparison to radiologist assessment, the use of AI to pre-screen patients with low-dose CT lung cancer screening provided a 12 percent reduction in mean interpretation time with a slight increase in specificity and a slight decrease in the recall rate, according to new research.
Meta-Analysis Shows Merits of AI with CTA Detection of Coronary Artery Stenosis and Calcified Plaque
April 16th 2025Artificial intelligence demonstrated higher AUC, sensitivity, and specificity than radiologists for detecting coronary artery stenosis > 50 percent on computed tomography angiography (CTA), according to a new 17-study meta-analysis.