MedTech News
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NeurAxis wins expanded FDA clearance for non-implanted neurostim for pain relief
NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve stimulator.
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COBRA-OS device receives special mention in TIME’s Best Inventions of 2024
Front Line Medical Technologies Inc, a leader in medical devices for emergency and trauma care, has announced that its COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System) has been specially recognised in TIME’s Best Inventions of 2024.
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Sense Neuro Diagnostics Awarded $2 Million Contract to Advance Brain Hemorrhage Detection Technology for Traumatic Brain Injury (TBI)
CINCINNATI, Nov. 4, 2024 /PRNewswire/ — Sense Neuro Diagnostics, a leader in developing technology for the diagnosis and monitoring of brain injuries, today announced it has been awarded a $2 million contract by the Department of Defense (DoD).
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SeeMedX Files 510(k) with FDA for Innovative Cardiac Monitoring System to Transform Heart Failure Care
LAS VEGAS, Nov. 4, 2024 /PRNewswire/ — SeeMedX Inc. (“SeeMedX”) today announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its innovative, non-invasive cardiac monitoring device, designed to allow medical professionals to have real-time insights into cardiac performance and fluid status
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FDA clears Quanta home hemodialysis system
Quanta Dialysis Technologies announced today that it received FDA 510(k) clearance for the use of its dialysis system in the home.
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R3 Vascular wins FDA IDE for drug-eluting scaffold
R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold.
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FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
iRhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and labeling updates.
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SynCardia picks up patent for total artificial heart
SynCardia announced today that it received a second patent expanding the coverage of its fully implantable artificial heart technology.