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    • Overview
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Home | About | Blog

Attaining Device Usability Success Through Human Factors Validation

Posted on November 7, 2023

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

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SeaStar Nabs Breakthrough Device Designation for Hepatorenal Syndrome

Posted on

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

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Insulet Omnipod 5 iPhone App FDA Cleared

Posted on

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

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iStar Brings Its Minimally Invasive Glaucoma Surgery device to Ireland

Posted on

The minimally invasive glaucoma surgery (MIGS) marks an expansion of iStar’s commercial rollout in Europe.

Read the full article at: www.mddionline.com

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Medtronic claims FDA approval for defibrillator implant routed outside the heart and veins

Posted on

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

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Pleural Dynamics Nabs FDA Clearance for ACES System

Posted on

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

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FDA clears miniature Micromate robot for CT-guided needle biopsies, interventional procedures

Posted on

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

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BD taps new FDA clearance for its ‘one-stick’ hospital blood draw system

Posted on

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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FDA Create New Digital Health Advisory Committee

Posted on

The committee will advise FDA on digital health technology issues by providing relevant expertise related to the benefits, risks, and outcomes in the space.

Read the full article at: www.mddionline.com

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FDA clears Neurovalens’ neurostim headset for chronic insomnia

Posted on

People suffering from chronic insomnia now have a new, drug-free option to treat the condition in the U.S.

Read the full article at: www.fiercebiotech.com

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Our specialized resources and experience enable us to build almost any medical device, and we have been doing so for nearly three decades. Omnica has partnered with startups and industry leaders alike to deliver world-class results that speak for themselves.

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Jorg Lorscheider

Jorg Lorscheider is the director of sales and marketing at Omnica and has been involved in product development and manufacturing for over 25 years.

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