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French LVAD Maker Aims to Fill Void Left By Medtronic
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Medtronic’s exit from the left ventricular assist device (LVAD) market left a huge void. A small French company wants to fill it.
Read the full article at: www.mddionline.com
Continue Reading »Microfluidic Chip Aids Tuberculosis Diagnosis
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Researchers at the University of London have collaborated with QuantuMDx, a medtech company based in the UK, to develop a microfluidic diagnostic device…
Read the full article at: www.medgadget.com
Continue Reading »Beckman Coulter Life Sciences leading the way to help labs comply with confidence for upcoming annex 1 regulation deadline
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Beckman Coulter Life Sciences, a global leader in laboratory automation and innovation, continues its relentless commitment to providing laboratories of all sizes with individualized and tailored support to meet the evolving list of regional and global compliance requirements.
Read the full article at: www.news-medical.net
Continue Reading »UK Health Officials Embrace AI Diagnostic Tools
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With an investment of £21M, health officials launch an ambitious plan to leverage AI diagnostic tools for stroke, cancer, and heart conditions.
Read the full article at: www.mddionline.com
Continue Reading »Galen Robotics nets FDA de novo clearance for ENT surgical helper
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The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument, with the goal of reducing natural hand tremors.
Read the full article at: www.fiercebiotech.com
Continue Reading »BD earns updated FDA nod for beleaguered Alaris infusion pumps
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Since early 2020, Alaris infusion pumps have received more than half-a-dozen hardware and software recalls. Now BD hopes to get them back on track.
Read the full article at: www.fiercebiotech.com
Continue Reading »Bone Bolt system for treating complex fractures earns FDA nod
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Proving that you can, indeed, teach an old dog new tricks, the University of Utah earned its first 510(k) FDA clearance at the ripe old age of 173.
Read the full article at: www.fiercebiotech.com
Continue Reading »Renalytix nabs FDA nod for AI-powered kidney disease test
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Nearly three years in the making, Renalytix has finally reeled in the FDA’s authorization for a test to predict oncoming declines in kidney function.
Read the full article at: www.fiercebiotech.com
Continue Reading »Regulatory affairs specialist pleads guilty to forging FDA clearance documents
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A regulatory affairs specialist has pleaded guilty to forging FDA documents and leading his bosses to believe they had a green light.
Read the full article at: www.fiercebiotech.com
Continue Reading »Tandem’s miniaturized insulin pump nets FDA nod
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The next big thing on Tandem Diabetes Care’s technology slate is actually a very small thing.
Read the full article at: www.fiercebiotech.com
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