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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Dec. 24, 2018

View Archived Issues

FDA draft for benefit-risk uncertainty knocked for panel hearing default

The U.S. FDA draft guidance addressing uncertainty in making benefit-risk determinations for class III devices was well-received by device makers on several points, but there was one recurring theme in the comments to the docket. That theme was an opposition to the draft guidance's default to the use of an FDA advisory committee hearing to address questions about postmarket data collection for devices regulated under the PMA, de novo and humanitarian exemption programs, a provision that, if sustained, could create considerable uncertainty regarding a device's place on the market. Read More

Global team develops fast, portable platform for diagnosing Ebola

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Smith & Nephew to buy Ceterix for up to $105M to advance meniscal repair

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Think3D opens $6M facility to facilitate 3D printing

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Investment in Australian life sciences on the rise but at a conservative clip

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Holiday notice

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Regulatory front

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Appointments and advancements

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BioWorld MedTech stock report for public med-tech companies

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Financings

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Product briefs

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Other news to note

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BioWorld MedTech's Neurology Extra

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