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Encore Medical's reworking of its Speedblock surgical instruments caused the premature failure and splitting in half of the devices during surgery, prompting a recall of the product, the FDA said in a recent warning letter.
Reporting on the recent American Academy of Orthopaedic Surgeons meeting, Merrill Lynch Research analyst Michael Jüngling highlighted trends in orthopedic surgery and their impact on the orthopedic device market.
A series of studies comparing drug-eluting stents with bare-metal stents points to an emerging consensus that the longer the drug-eluting devices remain implanted, the greater chances are that patients will develop life-threatening blood clots (thromboses).
Eleven women from various states filed a personal injury lawsuit Feb. 9 in Los Angeles Superior Court against Johnson & Johnson (J&J) and other companies that manufactured, marketed and distributed the Ortho Evra birth control prescription patch.
In a letter published the most recent issue of the New England Journal of Medicine, molecular pathologist and attorney Roger Klein of the Yale University School of Medicine questions the validity of patents used to prevent clinical laboratories from performing certain genetic tests.
The FDA's proposal to regulate complex genetic laboratory-developed tests (LDTs) could stifle the development and marketing of new diagnostics, presenters said at a recent public meeting.
Legislation is currently pending in the New Jersey Senate that would require insurance companies to pay all or part of the cost of hearing aids for children born with hearing loss.
A member of the Texas House of Representatives, Rep. René Oliveira (D), has introduced a bill that would require insurers to reimburse certain tests for heart disease.
Devicemakers need to ensure their subsidiaries working in foreign markets are aware of a U.S. anti-bribery law or -- as Johnson & Johnson (J&J) may find all too soon -- they could face multimillion-dollar fines and possible jail time for their officers.