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The FDA’s IT systems need to be upgraded to allow for effective receipt and management of electronic submissions, but budget shortfalls continue to limit the agency’s progress on the technology front, according to the agency’s top official.
The recent rash of highly publicized malfunctions and recalls regarding implantable cardioverter-defibrillators (ICDs) manufactured by companies including Guidant, Medtronic and St. Jude has led some industry analysts and patients to question whether implantable devices are lifesavers or the source of additional patient risk.
St. Jude Medical has voluntarily notified physicians serving patients who have received certain models of the company’s implantable cardioverter-defibrillators (ICDs) that such patients are in need of noninvasive software upgrades to their devices to correct two product anomalies.
Three-quarters of the regulatory professionals polled in a recent survey expect to implement electronic common technical document (eCTD) submissions, up from 58 percent last year.
Researchers have determined that babies treated in neonatal intensive care units (NICUs) with medical devices containing polyvinyl chloride (PVC) plastic are exposed to high levels of the toxic chemical “phthalate.”
MIV Therapeutics (MIVT) will license two technologies from the University of British Columbia (UBC) for advanced biocompatible and drug-eluting coatings for stents and other medical devices, the company announced last week.
The FDA has cleared Medtronic’s new multipurpose catheter for the temporary occlusion of large blood vessels and the expansion of vascular prostheses in procedures treating and repairing patients’ aortas.
A UK-based analyst and consulting firm specializing in applying mobile and wireless technologies to the healthcare sector recently issued a report detailing 101 ways in which cell phones can be put to use for individual patient care services.