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FDA clears miniature Micromate robot for CT-guided needle biopsies, interventional procedures
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Interventional Systems’ Micromate robot for needle-based procedures has received a new clearance from the FDA that broadens its use to CT imaging.
Read the full article at: www.fiercebiotech.com
Continue Reading »BD taps new FDA clearance for its ‘one-stick’ hospital blood draw system
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BD is building on its goal of providing patients with a “one-stick hospital stay,” with a new FDA clearance for painless blood collection hardware that works through already-placed IV lines.
Read the full article at: www.fiercebiotech.com
Continue Reading »FDA Create New Digital Health Advisory Committee
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The committee will advise FDA on digital health technology issues by providing relevant expertise related to the benefits, risks, and outcomes in the space.
Read the full article at: www.mddionline.com
Continue Reading »FDA clears Neurovalens’ neurostim headset for chronic insomnia
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People suffering from chronic insomnia now have a new, drug-free option to treat the condition in the U.S.
Read the full article at: www.fiercebiotech.com
Continue Reading »The Problem with FDA’s Warning to Abiomed
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This week in Pedersen’s POV, our senior editor addresses a controversial FDA warning letter and its broader implications for medical device manufacturers.
Read the full article at: www.mddionline.com
Continue Reading »Hyperfine wins FDA nod to expand MRI image-sharpening AI
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The latest nod marks Hyperfine’s eighth FDA clearance in the span of three years for its MRI scanner-on-wheels.
Read the full article at: www.fiercebiotech.com
Continue Reading »FDA to form advisory committee for digital health and AI
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The FDA is enlisting a new panel of outside experts to help it get deeper into the AI weeds.
Read the full article at: www.fiercebiotech.com
Continue Reading »New tool reveals how drugs affect men, women differently — and will make for safer medications
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Researchers have developed a powerful new tool to understand how medications affect men and women differently, and that will help lead to safer, more effective drugs in the future.
Read the full article at: www.sciencedaily.com
Continue Reading »MRI-Compatible Stereotactic Neurosurgery Robot
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Dr. Gregory Fischer, in his keynote at BIOMEDevice Boston, discusses the journey from concept to commercialization for his MRI-compatible neurosurgery robot.
Read the full article at: www.mddionline.com
Continue Reading »The Approvals Keep Rolling in for Boston Scientific
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The Marlborough, MA-based company has won approval for the latest generation of its Watchman LAAC device.
Read the full article at: www.mddionline.com
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