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The FDA has issued a warning letter to a clinical trial site in Illinois for failing to submit an investigational new drug application (IND) before launching a clinical investigation of a combination drug-device product. Read More
C2N Diagnostics announced the planned launch of its new diagnostic blood test, PrecivityAD2, which uses mass spectrometry and a statistical algorithm to detect the two key drivers behind Alzheimer’s disease — tau and amyloid beta proteins. Read More
Women with breast or ovarian cancer had fewer hot flashes, less psychiatric distress and better quality of life after using XRHealth’s virtual reality (VR)-artificial intelligence (AI)- based technology, researchers reported in the journal Healthcare. Read More
A large part of the FDA inspection process is reviewing documents and those documents need to be accessible promptly on request, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
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