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.
Cancer care and software technology maker Varian announced that the FDA has granted an investigational device exemption (IDE) for a pivotal multi-center, international trial of its cardiac radioablation (CRA) system for patients with high-risk refractory ventricular tachycardia (VT). Read More
The FDA has sent Surmodics a Complete Response Letter for its SurVeil drug-coated balloon, asking the company to amend its premarket approval application (PMA) to add information on biocompatibility and labeling.
The FDA has granted a priority review for Purdue’s abbreviated new drug application for nalmefene prefilled syringes for complete or partial reversal of opioid overdose.