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Xēnix Medical Nabs 510(k) Clearance for neoWave Implants
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The interbody fusion implants received FDA nanotechnology designation.
Read the full article at: www.mddionline.com
Continue Reading »FDA advisers wave through first CRISPR-based therapy
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After Thursday’s advisory committee meeting, CRISPR and Vertex will now wait for an official FDA decision on exa-cel.
Read the full article at: www.fiercebiotech.com
Continue Reading »Attaining Device Usability Success Through Human Factors Validation
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Technology is landing in the hands of more end users of various populations. Determining what defines useability is shifting as a result.
Read the full article at: www.mddionline.com
Continue Reading »SeaStar Nabs Breakthrough Device Designation for Hepatorenal Syndrome
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The company’s Selective Cytopheretic Device may play a role in allowing kidneys to recover enough for patients to become liver transplant candidates.
Read the full article at: www.mddionline.com
Continue Reading »Insulet Omnipod 5 iPhone App FDA Cleared
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The iPhone app offers users an expanded opportunity to control and manage the Omnipod and Dexcom G6 via a smartphone.
Read the full article at: www.mddionline.com
Continue Reading »iStar Brings Its Minimally Invasive Glaucoma Surgery device to Ireland
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The minimally invasive glaucoma surgery (MIGS) marks an expansion of iStar’s commercial rollout in Europe.
Read the full article at: www.mddionline.com
Continue Reading »Medtronic claims FDA approval for defibrillator implant routed outside the heart and veins
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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.
Read the full article at: www.fiercebiotech.com
Continue Reading »Pleural Dynamics Nabs FDA Clearance for ACES System
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The device, according to the company, addresses the shortcomings of pleurodesis and indwelling pleural catheters when treating pleural effusion and ascites.
Read the full article at: www.mddionline.com
Continue Reading »FDA clears miniature Micromate robot for CT-guided needle biopsies, interventional procedures
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Interventional Systems’ Micromate robot for needle-based procedures has received a new clearance from the FDA that broadens its use to CT imaging.
Read the full article at: www.fiercebiotech.com
Continue Reading »BD taps new FDA clearance for its ‘one-stick’ hospital blood draw system
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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.
Read the full article at: www.fiercebiotech.com
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