Medtronic’s Renal Denervation Dreams Dashed Again
An advisory committee voted against Medtronic’s renal denervation system on Wednesday. FDA’s decision on premarket approval of the device looms.
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Continue Reading »Clario and AliveCor collaborate to offer advanced, trial-focused six-lead ECG solutions for monitoring in decentralized clinical trials
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…
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Continue Reading »LivaNova Nabs FDA Nod, CE-Mark for In-Line Blood Monitor
The Essenz monitor is integrated into the company’s perfusion system and provides continuous blood parameter measurements.
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Continue Reading »GenInCode Files FDA 510(k) Submission For Polygenic Cardiovascular Disease Risk Test
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
Continue Reading »FDA approves Boston Scientific’s afib-freezing catheter
Boston Scientific is giving new meaning to the polar plunge.
Read the full article at: www.fiercebiotech.com
Continue Reading »FDA OKs Fresenius’ at-home dialysis guidance software
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
Continue Reading »Hamilton duels ventilator issues in FDA Class I recall
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
Continue Reading »FDA clears new tampon design from Sequel
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.
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Continue Reading »Medtronic, Cydar Treat First Patient in AI Pilot Program
The collaboration includes 40 sites across the US, UK, and Europe with the goal to advance aortic patient treatment decisions.
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Continue Reading »Choosing the Right Medtech Product Development Consultancy
Expertise, experience, quality of answers, and work are key areas of interest in a partner qualification tool kit.
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