FDA clears a TransEnterix 510(k) clearance for 3 millimeter diameter instruments for its Senhance System for use in microlaparoscopic surgeries.
FDA approves a Boehringer Ingelheim supplemental NDA for new labeling on its Stiolto Respimat (tiotropium bromide and olodaterol) that includes data s...
FDA issues a safety alert following a Medtronic software update to address a risk caused by cybersecurity vulnerabilities associated with an Internet ...
Surgeon and anti-power morcellator activist Hooman Noorchashm petitions FDA to ban uncontained laparoscopic power morcellators used in some gynecologi...
CDER special assistant for labeling Iris Masucci uses a Webinar to provide detailed information on a draft guidance on the content and format of the I...
FDA awards $5 million to the National Capital Consortium for Pediatric Device Innovation, led by Children's National Health System and University of M...
Federal Register notice: FDA renews the charter of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years.
FDA clears a Transseptal Solutions 510(k) for the TSP Crosser Transseptal Access System, a transseptal puncture system with a built-in steering mechan...