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The FDA Aug. 17 posted to its website an Aug. 10 approval letter for the Tupos LV/ATx and Kronos LV-T cardiac resynchronization therapy defibrillators (CRT-Ds) and the Corox OTW Steroid Lead, manufactured by Biotronik.
The Irish Medical Devices Association (IMDA), which falls within the Irish Business and Employers Confederation, has called for "a concerted effort to be made across Europe" to establish a system to enable small European Union-based medical device and diagnostic companies to benefit from major reductions in fees when registering new product applications with the FDA.
After winning a lawsuit against the FDA, Utah Medical Products is taking another step in its battle with the agency, filing a petition with HHS saying the FDA should remove a two-year-old press release about the firm from its website.
A Troy-based company that pioneered a noninvasive medical device to help doctors prevent strokes in surgical patients will double its sales staff to 50 in anticipation of a new market in neonatal and pediatric intensive care units.