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Home » Authors » Richie Crider

Articles by Richie Crider

Doc societies ink new system to standardize coronary CTA reporting

June 20, 2016
By Richie Crider

FDA clarifies validation mandates for IVDs<

June 15, 2016
By Richie Crider

FDA clarifies how IDE categories work as they relate to Medicare coverage

June 3, 2016
By Richie Crider

Boston Scientific recalls Fetch 2 catheter amid breakage concerns

April 26, 2016
By Richie Crider

Company tells FDA it keeps no
records for design controls

April 19, 2016
By Richie Crider

Industry urges FDA to rethink public release of emerging signals

April 4, 2016
By Richie Crider

Unanimous Thumbs Down Vote: Advisory panel votes down Angel Med's Guardian system over trial data issues

March 18, 2016
By Richie Crider
GAITHERSBURG, Md. — The circulatory system advisory committee voted unanimously that the Angelmed Guardian alert system from Angel Medical Systems, Inc., is not effective and that the benefits do not outweigh the risks, also voting 8-4 that the device is not safe for use.
Read More

Industry lowers MDUFA demands in effort to cap user fee funding

March 16, 2016
By Richie Crider

FDA letter dings Repro-Med for unsupported claims, modifications

March 10, 2016
By Richie Crider

CDRH says MDFUA IV wish list adds about $500M to the tab

March 3, 2016
By Richie Crider
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