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Establishments that make eligibility determinations for certain donated human cells, tissues and cellular and tissue-based products should retest donors to ensure that faulty testing methods do not allow communicable diseases to be transmitted through those products, the FDA says.
With the rapid evolution of gene-based diagnostics and targeted drug therapies, a movement to protect the confidentiality of genetic information is picking up steam.
A federal appeals court Jan. 24 ruled that a lower court judge erred in interpreting some of the terminology in a patent related to hypodermic safety syringes.
The Washington Legal Foundation (WLF) is supporting a former regulatory affairs official's appeal of a recent court ruling that he conspired to sell a device that had not been approved by the FDA.
A company's right to challenge a patent it is licensed to use is not restricted by the licensing agreement between that company and the patent holder, the U.S. Supreme Court said in a recent ruling.
The success of the top U.S. heart-device manufacturers in 2007 will depend on the specific market forces individual firms are dealing with, analysts say.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a letter to physicians Jan. 24 to warn them about a component in a model of oxygen cylinder that could make the device hazardous when it is in proximity to magnetic resonance imaging (MRI) equipment.
The FDA's Neurological Devices Advisory Panel, which meets today, is likely to vote in favor of approving Neuronetics' NeuroStar device for depression, Lazard Capital Markets analyst Alexander Arrow said in a Jan. 24 research note.