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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

June 10, 2014

View Archived Issues

FDA Advisory Committee: Acufocus snares 4-3 affirmative vote for Kamra PMA at advisory

Acufocus (Irvine, California) managed to get across the finish line with a narrow win at a June 6 advisory committee hearing for the Kamra PMA despite losing a vote on device safety. The vote on whether the benefits appeared to outweigh the risks was 4-3 with one abstention, and it appeared the 7-1 effectiveness vote carried the day despite considerable misgivings expressed by a number of panelists during the course of the hearing, concerns that led to a 5-4 vote that the data did not conclusively demonstrate that the device is safe. Read More

Asia Biotech Invest 2014 Conference: Investors seek synergy between devices and IT

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NewCo on the Go: LensGen developing lens to adequately treat presbyopia

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Benson Medical combines hearing conservation, pulmonary function data

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World In Review: Clinigene International launches cholesterol efflux assay for ATP

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Agreements/contracts: Rosetta works with Moffitt for thyroid assay development

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Hit Bits: ZeOmega releases newest version of population management platform

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People in Places

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Product briefs

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MDD's Cardiology Extra

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