News of Note—Fujifilm's $1.6B deal with Hitachi; Novo's new virtual diabetes collab

FDA
News from around the medtech sector (FDA)

> Fujifilm announced it would acquire Hitachi’s diagnostic imaging business and fold it into its healthcare operations through a $1.6 billion deal. This would include artificial intelligence-powered image processing and other systems to be applied across its CT, MRI and endoscopic modalities. Hitachi plans to split off its diagnostics efforts into a new company before it is officially bought by Fujifilm. The deal is expected to be completed by July 2020. Release (PDF)

> Novo Nordisk is teaming up with the University of Virginia’s (UVA's) Center for Diabetes Technology on a five-year project to develop virtual simulations of metabolic systems. The goal is to model individuals within a population of patients with Type 2 diabetes. “We believe this technology has the potential to assist the design of advisory and automated support systems, and we are looking forward to working with Novo Nordisk to extend our research into improving care for patients with type 2 diabetes through data-driven models, analytics, computer simulation and artificial intelligence,” said UVA’s center director, Boris Kovatchev. Release

> Bayer received 510(k) clearance from the FDA to expand the use of its Medrad Stellant Flex CT injection system for use in contrast-enhanced mammographies. By using iodine-based X-ray agents, the procedure can help better visualize abnormalities in breast tissue compared to standard scans. Prior to the new clearance, the injection system was indicated for use specifically in CT scans. Release

> The FDA granted Eko a breakthrough device designation for its algorithm designed to help detect heart failure through a simple electrocardiogram conducted by its digital stethoscope. The tool could be used to screen patients for weaker levels of left-ventricular ejection fraction—or the percentage of blood expelled by the heart with every beat—using just 15 seconds of ECG data. Eko’s algorithm uses a deep learning neural network, developed with the Mayo Clinic. Release

RELATED: Eko bags $20M to expand digital stethoscope, grow footprint

> Karius published study results showing its bloodstream infection test was capable of detecting issues before the onset of symptoms in high-risk children with leukemia. The clinical study, performed at St. Jude Children’s Research Hospital, was published in JAMA Oncology. Karius’ blood test uses next-generation sequencing of microbial cell-free DNA to detect over 1,400 bacteria, DNA viruses, fungi and parasites, according to the company. It is primarily used to find specific pathogens in complicated pneumonia, cardiovascular infections and infections in immunocompromised patients. Release

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