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  • About
    • Overview
    • Team
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  • Work
    • Portfolio
    • Magnica – for the fun of it
  • Resources
    • Medical Device Product Development
    • Design Control for Medical Devices
    • Medical Device Prototyping
    • Medical Device Verification and Validation
    • Medical Device Design Services
  • Contact
    • Careers
  • Events
  • 949-472-0275
 

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Home | About | Blog

Staar Surgical scopes out FDA approval for LASIK alternative implantable lens

Posted on April 2, 2022

Years after initially setting its sights on FDA approval for the latest version of its implanted vision-correcting lens, Staar Surgical has finally reached the regulatory milestone.

Read the full article at: www.fiercebiotech.com

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New Products Posted to GenomeWeb: Miroculus, Oxford Nanopore, CareDx, More

Posted on

Miroculus Miro Canvas

Miroculus has launched a new digital microfluidics platform that can carry out on-demand automation of complex next-generation sequencing sample preparation protocols.The instrument was unveiled during the Advances in Genome Biology and Technology meeting in February 2020,……

Read the full article at: www.genomeweb.com

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Wision A.I. secures FDA nod for polyp-spotting colonoscopy tech

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One down, one to go. After locking down its first FDA clearance, Wision A.I. is already lining up its next regulatory score.

Read the full article at: www.fiercebiotech.com

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Lessons from the Evolution of the Automated External Defibrillator

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Researchers credit rapid prototyping & user-centric design key to developing the small, light, portable automated external defibrillator.

Read the full article at: www.mddionline.com

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Medtronic Isn’t Ready to Throw in the Towel on Renal Denervation

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Medtronic still seems confident about its renal denervation opportunity, but investors have “mostly given up,” a medtech analyst observes.

Read the full article at: www.mddionline.com

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Device Makes Diffuse Ultrasound Waves for Intracranial Applications | Medgadget

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Researchers at the University of California San Diego created an ultrasound transducer that is intended to provide safer ultrasound treatment when working inside the brain. 

Read the full article at: www.medgadget.com

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CloudCath Wins FDA Nod for Connected Device for Home Dialysis

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A cloud-based digital connection enables communication of dialysis data with physicians.

Read the full article at: www.mddionline.com

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Some Diagnostics Companies Can Breathe a Sigh of Relief

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EU Commission’s recently approved IVDR proposal means a sigh of relief for some IVD manufacturers, regulatory experts say.

Read the full article at: www.mddionline.com

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Gone Are the Days of Europe-First Medical Devices

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Did new regulations kill innovation for medical devices in the European Union? A new industry report suggests that pursuing CE mark has lost its appeal.

Read the full article at: www.mddionline.com

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MD&M West is This Month! April 12 – 14

Posted on April 1, 2022

If you would like to attend the show please register with code “West22”  You can register for the show floor for free.  If any of you are planning to attend, […]

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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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