Covidien (NYSE:COV) won 510(k) clearance from the FDA for its Endo Gia surgical stapler.
The Endo Gia, which uses an advanced polymer felt material to provide additional support to fragile tissue, landed Japanese approval in late January.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Covidien (NYSE:COV) won 510(k) clearance from the FDA for its Endo Gia surgical stapler.
The Endo Gia, which uses an advanced polymer felt material to provide additional support to fragile tissue, landed Japanese approval in late January.
The FDA’s office of medical device review released its priorities for the year ahead, saying that it plans to focus on its clinical trial process and promote a better balance between pre- and post-market data aggregation.
DexCom Inc. (NSDQ:DXCM) said it secured FDA approval for its DexCom G4 Platinum continuous glucose monitor for diabetic children ages 2 to 17.
By: Chris Mulieri
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
By: Jesse Goodman, M.D., M.P.H.
Technology titan Apple Inc. (NSDQ:AAPL) sent a few executives to the FDA late last year to meet with agency officials to talk about "mobile medical applications," according to the FDA’s public calendar.
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has released two new draft guidances for medical device manufacturers that either include computational modeling data in their registration applications or use animal-derived sources in their products.
MASSDEVICE ON CALL — The FDA this month issued a formal warning to the Institutional Review Board of Mercy Hospital & Medical Center, citing the committee for violations of policies regarding human clinical testing.
The feds noted record-keeping and protocol violations regarding the board’s clinical trial , the keeping of meeting minutes and other breaches, and said that the board’s initial responses to some of the concerns were "inadequate."
MASSDEVICE ON CALL — Based on the results of a newly unveiled study, the FDA plans to implement new processes to ensure that women make up an appropriate portion of medical device post-approval studies.