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Home | About | Blog

Medtronic’s Renal Denervation Dreams Dashed Again

Posted on September 7, 2023

An advisory committee voted against Medtronic’s renal denervation system on Wednesday. FDA’s decision on premarket approval of the device looms.

Read the full article at: www.mddionline.com

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Clario and AliveCor collaborate to offer advanced, trial-focused six-lead ECG solutions for monitoring in decentralized clinical trials

Posted on

Clario and AliveCor collaborate to offer advanced, trial-focused six-lead ECG solutions for monitoring in decentralized clinical trials – read this article along with other careers information, tips and advice on BioSpace…

Read the full article at: www.biospace.com

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LivaNova Nabs FDA Nod, CE-Mark for In-Line Blood Monitor

Posted on

The Essenz monitor is integrated into the company’s perfusion system and provides continuous blood parameter measurements.

Read the full article at: www.mddionline.com

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GenInCode Files FDA 510(k) Submission For Polygenic Cardiovascular Disease Risk Test

Posted on

The test recently received a CPT PLA code and is currently offered through GenInCode’s laboratory in Irvine, California.

Read the full article at: www.precisionmedicineonline.com

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FDA approves Boston Scientific’s afib-freezing catheter

Posted on

Boston Scientific is giving new meaning to the polar plunge.

Read the full article at: www.fiercebiotech.com

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FDA OKs Fresenius’ at-home dialysis guidance software

Posted on

The GuideMe software is meant to give patients and their nurses more confidence as they transition from in-clinic to at-home dialysis sessions.

Read the full article at: www.fiercebiotech.com

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Hamilton duels ventilator issues in FDA Class I recall

Posted on

As ventilators have become increasingly crucial amid the COVID-19 pandemic, malfunctioning devices have been a constant burr in the FDA’s side.

Read the full article at: www.fiercebiotech.com

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FDA clears new tampon design from Sequel

Posted on

It’s not often that a sequel is better than the original, but one startup developing a new approach to period products is banking on it.

Read the full article at: www.fiercebiotech.com

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Medtronic, Cydar Treat First Patient in AI Pilot Program

Posted on

The collaboration includes 40 sites across the US, UK, and Europe with the goal to advance aortic patient treatment decisions.

Read the full article at: www.mddionline.com

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Choosing the Right Medtech Product Development Consultancy

Posted on

Expertise, experience, quality of answers, and work are key areas of interest in a partner qualification tool kit.

Read the full article at: www.mddionline.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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