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  • About
    • Overview
    • Team
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  • Work
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    • Magnica – for the fun of it
  • Resources
    • Medical Device Product Development
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    • Medical Device Design Services
  • Contact
    • Careers
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  • 949-472-0275
 

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Home | About | Blog

Galen Robotics nets FDA de novo clearance for ENT surgical helper

Posted on July 30, 2023

The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument, with the goal of reducing natural hand tremors.

Read the full article at: www.fiercebiotech.com

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BD earns updated FDA nod for beleaguered Alaris infusion pumps

Posted on

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.

Read the full article at: www.fiercebiotech.com

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Bone Bolt system for treating complex fractures earns FDA nod

Posted on

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.

Read the full article at: www.fiercebiotech.com

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Renalytix nabs FDA nod for AI-powered kidney disease test

Posted on

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.

Read the full article at: www.fiercebiotech.com

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Regulatory affairs specialist pleads guilty to forging FDA clearance documents

Posted on

A regulatory affairs specialist has pleaded guilty to forging FDA documents and leading his bosses to believe they had a green light.

Read the full article at: www.fiercebiotech.com

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Tandem’s miniaturized insulin pump nets FDA nod

Posted on

The next big thing on Tandem Diabetes Care’s technology slate is actually a very small thing.

Read the full article at: www.fiercebiotech.com

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FDA approves Abbott’s dual-chamber leadless pacemaker

Posted on

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.

Read the full article at: www.fiercebiotech.com

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Top 10 Wearable Technology Trends

Posted on

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.

Read the full article at: www.designnews.com

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AI-Powered Pain Relief: Interview with Claire Smith, VP at Nevro

Posted on

Nevro, a medtech company based in California, has developed the HFX iQ spinal cord stimulation system, which is intended to treat chronic pain.While…

Read the full article at: www.medgadget.com

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Dialysis on the Go? Working Toward an Artificial Kidney Device

Posted on

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.

Read the full article at: www.designnews.com

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About Omnica

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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