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Devicemakers are having difficulty making sense of a recent FDA final guidance targeting clinical decision support software (CDS) for machine learning (ML) products, according to remarks made during a virtual panel held Thursday by the Food and Drug Law Institute (FDLI). Read More
As demand for wearable medical devices that track health measures continues to rise, manufacturers will have to navigate the very real concerns of data privacy as well as more closely define whether a device is clinical or consumer-facing, according to panel members speaking Thursday at a Food and Drug Law Institute webinar, Current Developments in Digital Health Technology and Regulation. Read More
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