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BioWorld - Thursday, January 1, 2026
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Aug. 22, 2016

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Edwards bolsters position in growing TAVR market with FDA nod for intermediate risk

Edwards Lifesciences Corp. is poised to reap major benefits following the FDA's decision to expand the indications of two transcatheter aortic valve replacement (TAVR) devices. The company's Sapien 3 and XT transcatheter valves now will be an option for patients who are at intermediate risk for death or complications associated with open-heart surgery. Read More

IVDs must be recertified under stricter rules with clinical evidence

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Regulatory vet Bos says don't underestimate the revamped cost of compliance, re-labeling

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Steerable catheter aims to outmaneuver rivals

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Study indicates afib present in 12 percent of PCI-treated patients

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Daily M&A

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Other news to note

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Financings

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Product briefs

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MDD's Neurology Extra

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