Sentence examples for approval of the device from inspiring English sources

The advice to deny approval of the device is not binding on the F.D.A.

The researchers are seeking Food and Drug Administration approval of the device.

In March, an advisory panel to the Food and Drug Administration unanimously recommended approval of the device.

The F.D.A. request for more information may "modestly delay" approval of the device, said a Morgan Stanley analyst, Glenn Reicin, in a note to clients.

The company is preparing an application for the Food and Drug Administration for approval of the device, which he said was already being used by a handful of doctors.

Approval of the device, called Cypher, makes Johnson & Johnson the first on the market in the United States with a stent coated with a drug that prevents surgically cleared arteries from later reclogging with scar tissue.

The Centers for Medicare and Medicaid Services, the agency that administers Medicare, said that none of the clinical trials used to gain F.D.A. approval of the devices included patients over 60, leaving Medicare with no basis for saying the devices were a reasonable or necessary therapy for such patients.

And while its forecast takes the view that consumers' concerns about privacy will have been "largely" mitigated by 2020 — on account of what it describes as "educational efforts, adoption by peers and regulatory approvals of the device category" — Atwal rows back on this line somewhat.

Dr. Elbaum's company is conducting clinical trials in hopes of winning approval for the device from the Food and Drug Administration.

If Dr Vito and his team manage to commercialise artery stretching, though, approval by America's Food and Drug Administration would only require approval of the stretching device.

The expected FDA approval of the aortoiliac device and a larger variety of graft sizes should expand the number of patients who can be treated with this system.