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 looking to maximize reimbursement for their products should focus on taking a team-oriented approach to the reimbursement process, according to reimbursement and development experts.
The FDA has rejected Cardima’s premarket approval (PMA) application for its Revelation Tx microcatheter, marking the second time in a year that the agency has derailed the device.
Digital radiography systems have significant potential to increase the productivity of technologists and lower the dose of radiation experienced by patients, but that potential has not been realized yet, according to a radiology expert.
At the urging of the Orthopaedic Surgical Manufacturers Association (OSMA), an FDA advisory panel has recommended that the total mobile bearing knee (MBK) and unicompartmental MBK be reclassified from Class III to Class II.
The healthcare industry is in dire need of a national, centralized repository of recalls to ensure hospitals can respond to device alerts quickly, but it isn’t likely to get one anytime soon, according to industry experts and regulatory officials.
The FDA’s Circulatory System Devices Panel voted June 8 to not recommend approval of expanded indications for World Heart’s Novacor left ventricular assist device (LVAS).
Senate Finance Committee Chairman Charles Grassley (R-Iowa) is alleging his investigation into allegations the FDA withheld information about a possible link between antidepressant use and suicide in children is being thwarted by FDA managers.
Brand pharmaceutical firms facing generic competition must persuade an increasingly skeptical judiciary that their patents are not only valid but worthy of protection, according to a brand drug attorney at the Biotechnology Industry Organization (BIO) annual conference this week.