Attaining Device Usability Success Through Human Factors Validation
Technology is landing in the hands of more end users of various populations. Determining what defines useability is shifting as a result.
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Continue Reading »SeaStar Nabs Breakthrough Device Designation for Hepatorenal Syndrome
The company’s Selective Cytopheretic Device may play a role in allowing kidneys to recover enough for patients to become liver transplant candidates.
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Continue Reading »Insulet Omnipod 5 iPhone App FDA Cleared
The iPhone app offers users an expanded opportunity to control and manage the Omnipod and Dexcom G6 via a smartphone.
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Continue Reading »iStar Brings Its Minimally Invasive Glaucoma Surgery device to Ireland
The minimally invasive glaucoma surgery (MIGS) marks an expansion of iStar’s commercial rollout in Europe.
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Continue Reading »Medtronic claims FDA approval for defibrillator implant routed outside the heart and veins
Unlike other ICDs that are wired into beating hearts through the body’s veins, the Aurora’s electrical leads can be placed outside of the cardiac muscle and blood vessels to help reduce the risks of long-term complications.
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Continue Reading »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.
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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.
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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.
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