How Abbott’s Newest Indication Is Reshaping Heart Failure Management
The company has won a new indication for the CardioMems Sensor to be implanted in NYHA Class II patients.
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Continue Reading »University Hospitals Ventures expands collaboration with Lazurite
When approved by the U.S. Food and Drug Administration (FDA), the ArthroFree system is expected to be the first wireless surgical camera system for the minimally invasive operating room.
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Continue Reading »Eko Launches Redesigned App to Screen for Heart Disease
FDA’s clearances are for artificial intelligence (AI) algorithms that detect leading indicators of heart disease.
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Continue Reading »Navigating the Novel Medical Device Journey
A look at one company’s path from medical device design to market delivery yields some interesting lessons.
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Continue Reading »FDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls | FDA
FDA issues guidance to help companies prepare to quickly and effectively remove violative products from the market and limit the public’s exposure to risk.
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Continue Reading »FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments | FDA
FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments…
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Continue Reading »A Wearable Vein Dilation Device Could Help Dialysis Patients
A vascular surgeon thought there should be a better way to make patients’ veins bigger to prepare for dialysis. So he invented one.
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Continue Reading »Novanta Partners with MassRobotics for next-gen medical robotics
Novanta business units Celera Motion and ATI Industrial Automation will collaborate with MassRobotics to enable new innovations in medical/surgical robotics and other applications.
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Continue Reading »FDA clears Tandem’s smartphone app for programming insulin doses
There’s an app for just about everything these days, and now, that even includes one to program insulin doses throughout the day—though only for a very specific cross-section of i…
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Tags: RegulationContinue Reading »FDA Medical Device Classes Overview
Click to Expand If you were to undergo a pacemaker implant procedure, you would want assurance that the medical device to be surgically implanted into your body is subjected to […]
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