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The FDA and the Centers for Medicare & Medicaid Services announced Wednesday a two-year extension of the parallel review pilot program for medical devices, saying they need more time to evaluate the program’s effectiveness. Read More
Jay Crowley, who has been the FDA’s leading voice in explaining unique device identification to industry, is leaving the agency to join a California regulatory consulting group. Read More
The FDA’s medical device center may prequalify scientifically validated tools to support the development and regulatory evaluation of new devices. Read More
San Up, a Buenos Aires maker of piston and ultrasonic nebulizers, was warned by the FDA after cleaning shortfalls and other good manufacturing practice slip-ups. Read More
Medtronic is expanding its presence in Puerto Rico, with plans to invest $6 million and create 150 new jobs over the next three years, an island business group says. Read More
Morristown, N.J.-based Temptime said Wednesday it has completed its acquisition of William Laboratories, deepening the company’s footprint in the blood temperature monitoring market. Read More
Medical students and faculty at the University of Florida, along with one high school student, have released an app that can measure the battery life in deep brain stimulation devices. Read More