Judges side with FDA in rejecting stem cell device

(AP)—A federal appeals court is siding with the Food and Drug Administration in a case brought by medical device maker Cytori, ruling that the agency was correct to reject fast-track approval for two company devices used to process adult stem cells.

Cytori makes the Celution and StemSource devices which separate from fat tissue using a combination of spinning motions and . The company asked the FDA to approve the devices using a fast-track pathway reserved for devices that are similar to products already on the market. Cytori argued that its devices are similar to devices used to process blood and bone marrow.

A three-judge panel said the FDA was right to reject that argument and to require the company to apply through a more rigorous process.

3.7 /5 (3 votes)
add to favorites email to friend print save as pdf

Related Stories

FDA aims to accelerate medical device reviews

Feb 08, 2011

(AP) -- Federal health officials have proposed a plan that would speed up the approval of innovative medical devices that hold the potential to dramatically improve patients' lives.

FDA plans modest changes to medical device system

Jan 19, 2011

(AP) -- The Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices, which has been subject to increasing criticism by public safety advocates.

FDA medical device approvals get external review

Sep 23, 2009

(AP) -- The Food and Drug Administration is asking the government's top medical advisers to review its system for approving certain types of medical devices, which has been criticized by safety advocates and government watchdogs.

Recommended for you

Express Scripts turns to AbbVie in huge hepatitis C deal

Dec 22, 2014

The nation's largest pharmacy benefits manager is throwing its weight into the fight over high-cost hepatitis C drugs with a coverage restriction that might ultimately lower prices and improve patient access ...

FDA OKs Cubist antibiotic for serious infections

Dec 20, 2014

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

User comments

Adjust slider to filter visible comments by rank

Display comments: newest first

nanotech_republika_pl
not rated yet Mar 23, 2013
They will move to Mexico.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.