GAITHERSBURG, Maryland – There is no novelty to the assertion that technology drives FDA's regulations, so the fact that FDA would convene a two-day session with the hematology and pathology devices advisory committee to discuss how to reliably employ digital images of pathology slides in diagnostic workups is not a surprise. (Medical Device Daily)
WASHINGTON — The Advanced Medical Technology Association (AdvaMed; Washington) held a session at its annual meeting titled "Demystifying the 510(k) Process," but the mood at the meeting was that if there's anything cryptic about the process, it's not where the process currently stands; it's where the process is headed. (Medical Device Daily)
WASHINGTON – The Advanced Medical Technology Association (AdvaMed; Washington) made use of its bully pulpit yesterday in a session during which the association's president and board chairman warned that the $40 billion tax on the device industry as embodied in the bill by the Senate Finance constitutes "a really devastating proposal for a large share of our membership." (Medical Device Daily)