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PMA and 501(k) Approvals

Today's Issue of Medical Device Daily

Sunday, October 23, 2016

Today's Headlines

Attorney says 510(k) changes in revised FDA draft puts all players on even footing

HONG KONG – In what sounds like the plot of a science fiction novel, U.S.-based research firm Gartner Inc. recently predicted that 10 percent of the population in developed countries will be living with 3-D printed items on or in their bodies by 2019. The technology is making a particularly strong move into Asian countries, including Singapore.

Smaller single-port device from Fortimedix is expected to address laparoscopic barrier

A single-port laparoscopic device designed to knock down a key barrier in the space has earned a financial boost just days ahead of the product s official U.S. launch.

Alere, Abbott agree to mediation, not much else in contested merger nuptials

A court battle between Alere Inc. and its potential acquirer Abbott Labs could be inching towards a resolution. The two sides agreed last week to work with a mediator to resolve the dispute, which has landed in the Delaware Chancery Court.

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