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Devicemakers typically want to create equipment maintenance, cleaning and calibration procedures using the same outline because all three functions present the same primary challenges: frequency, trending and operational limits. Read More
A proposed in vitro diagnostics reform bill that may end up in legislation reauthorizing device user fees could have a chilling effect on the development of infectious disease-specific tests, warns the American Society for Microbiology (ASM). Read More
Parsippany, N.J.-based Extremity Medical has filed a federal patent lawsuit against competitor Fusion Orthopedics, claiming that the company, which was cofounded by a former Extremity sales representative, is infringing on two of its patents. Read More
The FDA has given Class I designation, the highest level of risk, to Avanos Medical’s March 21 recall of its Cortrak*2 enteral access system because of the potential for serious patient injury or death if the device is misused. Read More
Virginia-based device manufacturer S. Jackson received a Form 483 for repeat corrective and preventive action (CAPA) and risk analysis deficiencies following a December inspection by the FDA of its Alexandria facility. Read More
Storage and handling standards are often an area where FDA inspectors find deficiencies. Most calibration documents — whether you contract the service out or do it internally — will show you all the data expected for the actual calibration of the instrument. Many manufacturers tend to fail when it comes to the procedures and requirements for the handling of the equipment. Read More
Diadem’s AlzoSure Predict blood-based biomarker test for early prediction of Alzheimer's disease (AD) can accurately forecast whether individuals will develop the disease six years prior to a diagnosis, according to research reported in the Journal of Prevention of Alzheimer's Disease. Read More