We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Devicemakers that operate in Brazil should be checking to see that none of their business holdings has been charged with corrupt practices — either in Brazil or elsewhere in the world, experts warned during a recent American Bar Association meeting devoted to the country’s new antibribery law. Read More
Devicemakers testing the Wi-Fi functionality of their products should simulate the radio frequency (RF) characteristics of a hospital and should use access points from different manufacturers, a recent white paper from Laird Technologies recommends. Read More
If some lawmakers get their way, the federal budget proposal for fiscal 2014 and 2015 now being negotiated will include a provision shielding FDA user fee revenue from any across-the-board sequestration cuts. Read More
A group of patients is asking for sanctions against Johnson & Johnson’s Ethicon unit following allegations the company destroyed thousands of documents related to ongoing pelvic mesh trials. Read More
Valencia, Calif.-based SetPoint Medical has hired Sagentia to develop a programming interface for a neuromodulation device designed to provide a lower-cost and lower-risk alternative to immunosuppressive drugs such as prednisone that treat chronic inflammatory diseases such as Crohn’s disease and rheumatoid arthritis. Read More
AngioDynamics is restructuring its operations in NY in order to focus on product rationalization, lean initiatives, supply chain optimization and enterprise resource planning. Read More
Avacen, maker of The Avacen Thermal Exchange System (TATES), was hit with a nine-citation FDA warning letter for failing to establish a host of essential GMP procedures. Read More
Faced with long waits for Brazilian good manufacturing practice certificates, some devicemakers are turning to the courts to speed up product registrations — and seeing their time to market cut in half, an expert says. Read More
Oculus Innovative Sciences has received 510(k) clearance for its Microcyn hydrogel for scars resulting from burns, surgery or trauma wounds, with the FDA recognizing the device as substantially equivalent to similar products. Read More
Angelcare is voluntarily recalling its Movement and Sound Monitors with Sensor Pads due to the risk of a pliable cord wrapping around a baby’s neck in the crib. Read More
An FDA investigator handed Chase Medical a Form 483 after the company’s manufacturing assembler admitted she does not always remember to document all in-process tests for the Tripod Heart Stabilizer devices. Read More