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More devicemakers are choosing the de novo approval pathway to get novel low-risk technologies to market quickly, thanks to changes in the way the FDA reviews these products that took effect two years ago. But knowing how to pitch a petition is key to success, an expert says. Read More
Danaher’s plan to snap up dental implant company Nobel BioCare and Roche’s purchase of InterMune helped drive a strong third quarter for life sciences mergers and acquisitions, a new report from PricewaterhouseCoopers shows. Read More
Devicemakers may need to redesign scores of products and change their sterilization methods if the Environmental Protection agency goes through with plans to classify ethylene oxide as carcinogenic when inhaled by humans. Read More
The FDA is ordering manufacturers of power morcellators to add a black box warning to the devices and telling consumers the products are unsafe in almost all instances. Read More
Medtronic officials said Tuesday that a large donation to the Medtronic Foundation plus the ongoing acquisition of Covidien led to an 8 percent decline in earnings in the second-quarter of fiscal 2015 compared with the previous year. Read More
Cataract patients who also have astigmatism may soon have a new option for restoring vision, if the FDA heeds a recent advisory panel recommendation. Read More
Minneapolis, Minn.-based Vascular Solutions will not get a state subsidy for job creation in the wake of a federal fraud indictment issued against the company and its CEO. Read More
HHS officials highlighted progress in developing new Ebola diagnostics during a Wednesday House hearing, but acknowledged that more companies are looking for government support to move their products quickly to market. Read More
A study on the optimal length of dual antiplatelet therapy following implantation of a drug-eluting stent shows that 30 months is better than one year in preventing certain adverse outcomes. Read More
Australia and New Zealand have abandoned plans for a joint drug and device regulatory authority, although both countries say they will continue to cooperate on mutually beneficial regulations. Read More
The American Clinical Laboratory Association and American Medical Association are promising an all-out fight to stop the FDA from requiring premarket applications for high-risk laboratory-developed tests. Read More