The FDA recently approved sofosbuvir as a once-daily oral treatment for hepatitis C, according to a Gastroenterology & Endoscopy News report.
Supply Chain
The U.S. Food and Drug Administration has approved Minneapolis-based Medtronic's CoreValve Transcatheter for use without undergoing an independent device advisory panel review for the product, according to a Medtronic news release.
A Markets and Markets report projects the portable medical device market to be valued at $20 billion by 2018, according to a news release.
The U.S. Food and Drug Administration has cleared Irvine (Calif.) Biomedical to market its Therapy Cool Flex Ablation Catheter as a treatment for typical atrial flutter.
The U.S. Food and Drug Administration has issued draft guidance regarding the implementation of the custom device exception in the Food, Drug and Cosmetic Act.
The market for medical device outsourcing and contract manufacturers as brand owners is expected to increase to more than $12 billion by 2018.
The U.S. Food and Drug Administration announced it has approved the first gel sealant that can be used for preventing leakage of fluid through the incision in a patient's cornea after cataract surgery with intraocular lens placement in adults.
Reducing the number of intensive care unit beds could increase care quality while reducing overall healthcare costs, playing into the idea of demand elasticity, according to an article in the Journal of the American Medical Association.
The U.S. Food and Drug Administration announced a recall on Boulder, Colo.-based Covidien's Puritan Bennet 840 Series ventilator.
Employees from the secretive Google X research group have met with members from the U.S. Food and Drug Administration who oversee and regulate eye devices and diagnostics for heart conditions, according to a Bloomberg report.