The average costs to earn FDA 510(k) clearance are $24 million, making up more than three-quarters of the cost to bring a medical device from the initial concept to the U.S. market, according to a Stanford University report titled "FDA…
Spinal Tech
Here are 50 orthopedic and spine surgery devices that were either launched by device companies or approved by the FDA within the past year. The devices are listed in alphabetical order and were gathered from the FDA 510(k) Clearance list…
Patients who received metal-on-metal hip replacements from Wright Medical reported satisfactory results and a low rate of osteolysis after a ten-year follow-up, according to a study published in the Journal of Bone and Joint Surgery.
A multi-center retrospective study of spine surgery patients treated with Mazor's SpineAssist were found to have accurate implant placement 98 percent of the time, according to a company news release.
The Southern Region Contracting Office intends to award Stryker a sole-source contract for preventative maintenance support on Stryker-manufactured beds at Brooke Army Medical Center in Houston, Texas, according to a report from Federal Business Opportunities.
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Aesculap Inc., a member of the B. Braun group of companies, is a surgical instrument and implant manufacturer with U.S. headquarters located in Center Valley, Penn. In addition to the over 20,000 Aesculap products on the market, the company currently…
NeoStem, a New York-based international biopharmaceutical company, reported $51.7 million in total revenues during the third quarter of 2010, an increase from the $157,700 total revenues reported during the third quarter of 2009, according to a company news release.
Small Bone Innovations, an orthopedic technologies company, has entered into an exclusive three-year distribution agreement in the Netherlands with Biomet Nederland BV, according to a Small Bone Innovations news release.
Smith & Nephew CEO David Illingworth recently spoke with the Wall Street Journal about the tough regulatory environment in the United States as a result of increased scrutiny by the Food and Drug Administration and the possibility of an overhaul…
TranS1, a Wilmington, N.C.-based medical device company, reported third quarter total revenues at $6.3 million, an 8 percent decrease over the revenues reported for the third quarter of 2009, according to a company news release.