Sentence examples for fda clearance from inspiring English sources

Gadolinium-based contrast agents (GBCAs), currently the only FDA-approved contrast agents for evaluation of the breast, received FDA clearance in 1988.

MobiSante, based in Redmond, Washington, has devised a smartphone-based ultrasound system that was granted FDA clearance in early 2011.

She said 23andMe submitted its first application for FDA clearance in July 2012 and submitted another application at the end of August, but admitted "we are behind schedule with our responses".

And they're in the process of gaining FDA clearance.

Mako's product, launched in June, has FDA clearance.

Parsing and plotting these data points on a graph requires FDA clearance, explains Dalal.

The DMI did not have FDA-clearance at the time the protocol was approved by the local ethics committee; therefore, standard PET/CT was always used first at standard time for oncological imaging.

"Our current clinical trials are laying the groundwork for our FDA 510(k) clearance.

MRS received FDA 510(k) clearance in 2008.

Still, the lack of clearance from the Food and Drug Administration (FDA-USA regulations) and lack of a CE-IVD mark (European regulations) for such testing, has greatly hampered its use in current clinical practice [ 50].

The enzyme kinetic parameters, Km and Vmax, and the intrinsic clearance (CLint) were determined using FDA-recommended, isoenzyme-specific model reactions with and without PSi nanoparticles.