Pleural Dynamics Nabs FDA Clearance for ACES System
The device, according to the company, addresses the shortcomings of pleurodesis and indwelling pleural catheters when treating pleural effusion and ascites.
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Continue Reading »FDA clears miniature Micromate robot for CT-guided needle biopsies, interventional procedures
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
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
The committee will advise FDA on digital health technology issues by providing relevant expertise related to the benefits, risks, and outcomes in the space.
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Continue Reading »FDA clears Neurovalens’ neurostim headset for chronic insomnia
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
This week in Pedersen’s POV, our senior editor addresses a controversial FDA warning letter and its broader implications for medical device manufacturers.
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Continue Reading »Hyperfine wins FDA nod to expand MRI image-sharpening AI
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
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
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
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
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