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A research team in Massachusetts has developed a “deep learning” tool that can search cardiac X-rays (CXR) to find patterns associated with atherosclerotic cardiovascular disease (CVD), accurately predicting major cardiac events over the span of 10 years, according to study results presented at the Radiological Society of North America meeting in Chicago, Nov. 27-Dec. 1. Read More
As part of its Medical Device Development Tools (MDDT) initiative, the FDA has developed a screening tool to aid in evaluating the biocompatibility of polymeric medical device components that contain color additives. Read More
Percussionaire was handed a Form 483 following an inspection of its Sandpoint, Idaho facility for not reporting a serious medical event and for not properly handling and reporting a firmware issue with some accessory devices. Read More
The FDA issued an update on Baxter Hillrom’s Sept. 30 recall of its WatchCare incontinence management system, declaring it a Class 1 recall because of the risk of serious injury or death. Read More
Lunit’s study of 55,579 mammograms showed an increased cancer detection rate and a lower patient recall rate using the company’s Insight MMG breast cancer artificial (AI) solution than a team of two radiologists, the South Korea-headquartered company reported. Read More
Companies need to know how to access their archives — day or night — when using a third party for document storage and preparing for an FDA inspection, an FDA inspections expert advised at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More