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Boston Scientific is currently in settlement talks with Israel-based stentmaker Medinol to resolve an ongoing lawsuit that has already been sent to trial.
The FDA has approved new glucose monitors from devicemakers Abbott and Medtronic, monitors the companies say will help simplify the process by which diabetic patients check their glucose levels.
On July 29, President Bush signed into law the “Patient Safety and Quality Improvement Act of 2005,” providing narrow liability protection to encourage the anonymous reporting of medical errors to newly created patient safety organizations (PSOs).
The FDA has granted Boston Scientific limited regulatory approval for its stent system used to treat ischemic stroke in adult patients, the company announced last week.
St. Jude’s line of stented-tissue valves has been approved by the FDA for use as replacements for malfunctioning native or prosthetic valves, the company announced last week.
Using metallic tracheal stents in patients with benign airway disorders can potentially cause “serious complications,” the FDA warned in a recently issued Public Health Notification.
Quest Diagnostics has agreed to a deal in which it will acquire LabOne, a Lenexa, Kan.-based provider of health-screening and risk-assessment services to life insurance companies, the company said early last week.
Just before Congress recessed for the month of August, Reps. David Hobson (R-Ohio) and John Tanner (D-Tenn.) introduced a bill in the House in an effort, said the legislators, to “remedy many of the competitive acquisition provisions of the Medicare Modernization Act (MMA) of 2003.”
The open public hearing (OPH) sessions held during FDA advisory committee meetings have increasingly become a venue for pharmaceutical industry-funded speakers who try to influence the outcome of the deliberations, contends a healthcare watchdog group.
The plastic surgery industry, advocacy groups, and even Capitol Hill have come out to strongly express their respective opinions on re-introducing silicone gel breast implants in the U.S. in the wake of the FDA’s approvable letter to breast implant manufacturer Mentor.