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Two Murrieta, Calif.-based medical device companies have received warnings from the Food and Drug Administration for a lack of quality control over the manufacturing or assembling process.
The Food and Drug Administration published guidance for medical device manufacturers that describes how the benefits and risks of certain medical devices are considered during the pre-market review.
Ascendx Spine announced it received FDA 510(k) clearance for its Acu-Cut Vertebral Augmentation System for treating vertebral compression fractures.
Wednesday, 14 March 2012 13:47

BioMimetic Reports 2011 Revenue

BioMimetic Therapeutics recently announced financial results for the fourth quarter of 2011, where it reported total revenue of $458,300, an increase over the same period last year.
The Food and Drug Administration granted 17 spine-related device clearances in February.
The Food and Drug Administration granted 44 orthopedic- and spine-related 510(k) clearances in February, according to an FDA report.
Globus Medical's Chairman and CEO David Paul announced reaching a settlement with the Food and Drug Administration to result complaints alleging the company violated the Food, Drug and Cosmetic Act with its former product, NuBone.
Surgeons from Sinai Hospital, part of LifeBridge Health, recently used the first externally controllable internal limb lengthening device with FDA clearance, the PRECICE Limb Lengthening System, which they helped co-develop, according to a LifeBridge news release.
DePuy Orthopaedics has received premarket supplemental approval for the use of TRUMATCH Personalized Solutions with its SIGMA RP Knee System, according to a company news release.
The Food and Drug Administration granted 19 spine-related device clearances in January, according to an FDA report.
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