News

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.
FDA's plan to phase out animal testing may hurt Charles River's revenues. The DCF model suggests that CRL presents an ...
Onward Medical announced today that it submitted its ARC-EX system for expanded FDA indication and for CE mark approval.
CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update on ...
Olympus announced recently that it is committed to addressing the concerns of the FDA around its device manufacturing in ...
Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...
Onward Medical submits two major regulatory applications for its ARC-EX system; seeking clearance to expand its indication for home use: Eindhoven, the Netherlands Saturday, July ...
Olympus is promising swift action to address concerns raised by the Food and Drug Administration (FDA) about some of its ...
FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United StatesCE Mark ...
GS1 US Barcode Assessment reveals that full UDI implementation is often impeded at the provider level. The Barcode Assessment ...