Thursday, 29 March 2012 10:11
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.
Wednesday, 28 March 2012 10:30
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.
Monday, 19 March 2012 10:19
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 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.
Tuesday, 13 March 2012 09:23
The Food and Drug Administration granted 17 spine-related device clearances in February.
Tuesday, 06 March 2012 11:16
The Food and Drug Administration granted 44 orthopedic- and spine-related 510(k) clearances in February, according to an FDA report.
Thursday, 01 March 2012 15:01
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.
Friday, 17 February 2012 15:12
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.
Thursday, 16 February 2012 11:16
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.
Tuesday, 14 February 2012 14:18
The Food and Drug Administration granted 19 spine-related device clearances in January, according to an FDA report.