Galen Robotics nets FDA de novo clearance for ENT surgical helper
The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument, with the goal of reducing natural hand tremors.
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Continue Reading »BD earns updated FDA nod for beleaguered Alaris infusion pumps
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.
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Continue Reading »Bone Bolt system for treating complex fractures earns FDA nod
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.
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Continue Reading »Renalytix nabs FDA nod for AI-powered kidney disease test
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.
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Continue Reading »Regulatory affairs specialist pleads guilty to forging FDA clearance documents
A regulatory affairs specialist has pleaded guilty to forging FDA documents and leading his bosses to believe they had a green light.
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Continue Reading »Tandem’s miniaturized insulin pump nets FDA nod
The next big thing on Tandem Diabetes Care’s technology slate is actually a very small thing.
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Continue Reading »FDA approves Abbott’s dual-chamber leadless pacemaker
Not long after Abbott presented the successful results of a trial of its Aveir DR dual-chamber leadless pacemaker system, it has secured FDA approval.
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Continue Reading »Top 10 Wearable Technology Trends
According to StartUS Insights, here are the key trends in technology we wear that helps us hear, see, and monitor our health and well-being.
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Continue Reading »AI-Powered Pain Relief: Interview with Claire Smith, VP at Nevro
Nevro, a medtech company based in California, has developed the HFX iQ spinal cord stimulation system, which is intended to treat chronic pain.While…
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Continue Reading »Dialysis on the Go? Working Toward an Artificial Kidney Device
A new technology in the works aims to give kidney dialysis patients a better quality of life by enabling them to complete their treatments anywhere, anytime.
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