Professor David Williams, retired from the University of Liverpool, discusses infections that possibly link to biomaterials in the most recent issue of EMDM. He explores how biomaterials can be factors in infection. He uses his experience with real cases to make some distinctions...
Materials testing, analysis, and consultancy firm CERAM (Stoke-on-Trent, Staffordshire, UK) has boosted its Web offerings to customers in the medical device industry with the launch of a revitalized Web site that provides expanded industry-specific services and a large resource of reports, white papers, and guidance documents. The free downloads cover reports on the role of...
January 12th, 2010
BioCeramic Therapeutics, a biomaterials company, and its principal founder and chief scientific officer, Molly Stevens of Imperial College London, have won the prestigious ACES Academic Enterprise Award (in the Life Sciences category), in...
December 11th, 2009
AdvanSource Biomaterials Corp. has filed a patent for its newly launched ChronoSil polymer product,
a silicone-urethane copolymer. This patent application relates to silicone-urethane copolymers and methods for making ChronoSil. ChronoSil can have many physical properties which are usually associated with polyurethanes, but also the feel and characteristics of silicones.
The...
December 1st, 2009
Invibio Biomaterial Solutions has been named an inaugural recipient of the Spine Technology Award in the category of biomaterials, bestowed in recognition of its innovative PEEK-OPTIMA® family of polyetheretherketone (PEEK) polymers (unfilled, image contrast and reinforced). Invibio President Michael Callahan accepted the award at the 2009 Spine Technology Awards banquet, on...
November 17th, 2009
While FDA’s new leadership touts the importance of exemplary science at the agency, a 47-page petition seeking the reconsideration of the agency’s August 4 final rule on mercury-containing dental amalgam trashes the science FDA used in it. The petition also alleges a selective literature search and says that the agency’s clear priority was to “defend at all costs the continued use...
October 8th, 2009
There is no timeline yet for doing it, but FDA still intends to regulate laboratory-developed tests (LDTs) under FDA “enforcement discretion,” CDRH acting director of chemistry and toxicology devices Courtney Harper told the RAPS annual meeting audience in September. LDTs are presently marketed under the Clinical Laboratory Improvement Amendments (CLIA) without agency premarket...
October 8th, 2009
FDA has published a draft guidance titled Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses. It contains recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices intended for detection or detection and...
October 8th, 2009
FDA has issued a Strategic Plan for Risk Communication, outlining the agency’s efforts to release more meaningful public health information. The plan lays out a framework for FDA to provide information about products to healthcare professionals, patients, and consumers. It also outlines how the agency oversees industry communications.
The agenda involves 70 specific actions for...
October 2nd, 2009
September 3rd, 2009
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