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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 21, 2016

View Archived Issues

FDA allows Bard to tweak IDE endpoint as drug-coated balloons take center stage

The FDA is allowing C.R. Bard Inc. to change the primary endpoint to six months in the company's investigational device exemption (IDE) study for the Lutonix 014 drug-coated balloon (DCB) percutaneous transluminal angioplasty catheter. The modification comes as DCB technology stands out as a hot topic among interventional vascular and cardiology physicians this week at the annual VIVA meeting in Las Vegas. Read More

Wuxi works with Autogenomics to tap into China's growing diagnostic market

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Bayer wins FDA okay for Kyleena contraceptive device after host of earlier product problems

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Alternatives to FDA regulation of lab tests pepper Senate hearing

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Other news to note

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FDA inks 'coordinated development' draft for antimicrobial drugs

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Financings

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Product briefs

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Daily M&A

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MDD's Oncology Extra

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