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The FDA July 12 and 13 will hold a public workshop and meeting on "The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers."
The FDA has published draft guidance for the review and inspection of premarket approval (PMA) applications under its bioresearch
monitoring (BIMO) program.
Devicemakers are pushing for legislative reforms to rein in the administrative and other fees collected by group purchasing organizations (GPOs) that contribute to Medicare cost pressures, according to an industry expert.
Invitrogen Corporation, a provider of essential life science technologies for disease research and drug discovery, and Solexa, Inc., a provider of next-generation genetic analysis systems, announced a collaboration through which Invitrogen will supply many of the reagents for Solexa's sequencing, gene expression, and small RNA analysis kits designed to be used with the Solexa Genome Analysis System.
Tm Bioscience Corporation, a leader in the commercial genetic testing market, today announced it has signed a distribution agreement with Sanbio b.v. to commercialize the ID-Tag Respiratory Viral Panel (RVP) from Tm in the Netherlands.
GE Healthcare, a division of the General Electric Company has begun a clinical study of a new chemical for use in positron emission tomography (PET) imaging that could be used to monitor angiogenesis, the formation of new blood vessels in tumours.
MRL, Inc., a Welch Allyn Company, today announced it is initiating a voluntary worldwide Class I recall of 580 AED20 Automatic External Defibrillators manufactured in Buffalo Grove, IL between April and October of 2003, with serial numbers 205199 through 205786.