Category: Food & Drug Administration (FDA)Syndicate content

Boston Scientific's bare-metal Rebel stent comes to the U.S.

July 21, 2014 by Arezu Sarvestani

Medtech titan Boston Scientific lands FDA approval for its Rebel bare-metal stent, made of the company's proprietary platinum chromium alloy.

Boston Scientific's bare-metal Rebel stent comes to the U.S.

Massachusetts medical device giant Boston Scientific (NYSE:BSX) today announced FDA approval for the latest in its line of coronary stents, the Rebel bare-metal stent.

FDA dings Spinal Elements for design changes, unreviewed claims

July 17, 2014 by Arezu Sarvestani

The FDA issues a formal warning letter to Spinal Elements, saying the company needs to seek new regulatory review for design changes and marketing claims for its spinal fusion devices.

FDA dings Spinal Elements for design changes, unreviewed claims

The FDA posted a warning letter against California-based Spinal Elements, saying that the company failed to obtain regulatory clearance for design changes to certain of its intervertebral body fusion devices.

FDA win lets SynCardia artificial heart patients out of the hospital

July 17, 2014 by Arezu Sarvestani

FDA regulators approval SynCardia's Freedom portable driver, allowing all clinically stable patients relying on the total artificial heart to be discharged from the hospital.

FDA win lets SynCardia artificial heart patients out of the hospital

Artificial heart maker SynCardia announced this week that it won FDA approval for its Freedom driver, a portable power driver that allows patients to take their artificial heart systems out of the hospital.

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