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The FDA published draft guidance June 20 to help devicemakers understand the process for the review of clinical and nonclinical information in premarket approval (PMA) applications and related inspections under the bioresearch monitoring (BIMO) program.
A non-invasive haemoglobin/hematocrit monitoring system developed by OrSense Ltd has been shown to accurately measure levels of haemoglobin/hematocrit in both hospital and ambulatory settings.
Acacia Research Corporation announced today that its CombiMatrix group's subsidiary, CombiMatrix Molecular Diagnostics (CMDX) is planning to commercially launch its first molecular diagnostic service offering in August, 2006.
ViaCell, Incannounced today the United States Food and Drug Administration (FDA) has conditionally approved its Investigational Device Exemption (IDE) to evaluate its ViaCyte(SM) investigational product offering for the cryopreservation and thawing of human
oocytes for use during assisted reproductive technology.
Abbott announced today that the U.S. Food and Drug Administration (FDA) approved the HUMIRA Pen, a new device for administering HUMIRA (adalimumab), a treatment approved for moderate to severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA).
Abiomed, Inc. today announced conditionalapproval by the U.S. Food and Drug Administration (FDA) of itsInvestigational Device Exemption (IDE) for the IMPELLA 5.0 unique,catheter-based Circulatory Support
Systems.
Health Discovery Corporation announced today that it has filed patent infringement lawsuits against Ciphergen Biosystems, Inc. ("Ciphergen") and Equbits LLC ("Equbits") in the United States District Court in Marshall, Texas.
The FDA recently issued a public health notice on the instructions for cleaning and sanitizing, or "reprocessing," ultrasound transducer assemblies used in biopsy procedures.
A key House Democrat is blasting the FDA's enforcement policies, arguing that the agency is falling down on the job in its efforts to protect public safety.
Device and diagnostics companies should integrate compliance standards more effectively into their sales and marketing efforts if they want to meet evolving regulatory requirements and avoid government enforcement actions, experts said at a recent industry conference.