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BioWorld - Tuesday, January 13, 2026
Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

Washington roundup: AdvaMed: 510(k) changes may foster 'tremendous confusion'

Oct. 7, 2010
By Mark McCarty

Hamburg: better regs the best defense against sensationalism

Oct. 7, 2010
By Mark McCarty

Washington roundup: Warning letter to investigator parallels letter to Pioneer

Oct. 5, 2010
By Mark McCarty

Washington roundup: Rosecrans exits CDRH, joins Schultz at Greenleaf Health

Oct. 4, 2010
By Mark McCarty

FDA warning letters show more scrutiny for personalized knee systems

Oct. 1, 2010
By Mark McCarty

Medartis sees low profile as route to a high profile future

Oct. 1, 2010
By Mark McCarty
The big names in the orthopedic sector in the U.S. are familiar and many are clustered in Warsaw, Indiana, but Switzerland has its own cluster of firms working this space. Among these is Medartis (Basel), which has zeroed in on innovative devices used to fix broken joints in the hands and feet and nearby anatomical locations. While the company is interested in building a reputation, its plan is to use a series of low-profile devices to build a high-profile brand. (Medical Device Daily)
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Washington roundup: AdvaMed chimes in on 510(k) while FDA ponders changes

Sep. 30, 2010
By Mark McCarty

Washington roundup: NIH offers 9 biomarkers for detection of ischemic stroke

Sep. 29, 2010
By Mark McCarty

Pocock on statistics: P values are 'no substitute for a brain'

Sep. 28, 2010
By Mark McCarty
WASHINGTON – This year's edition of Transcatheter Cardiovascular Therapeutics offered a host of sessions addressing clinical trial design and data, but one of the more thought-provoking sessions may have been the session addressing the meaning of the term "statistical significance," a very different animal than the even more rubbery term "clinical significance." (Medical Device Daily)
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LaViolette: some FDAers guilty of 'demonization of industry'

Sep. 27, 2010
By Mark McCarty
WASHINGTON – This year's edition of Transcatheter Cardiovascular Therapeutics offered an FDA town hall meeting as it did last year, but one difference was that Bill Maisel, MD, formerly of the Medical Device Safety Institute (Boston) made his public debut as an official at the agency's Center for Devices and Radiological Health. (Medical Device Daily)
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View All Articles by Mark McCarty

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