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Rapidly evolving federal guidance for people who have been exposed to COVID-19 or who have already tested positive is expected to further increase the demand for scarce diagnostic tests. Read More
Some data necessary to develop and implement a good corrective and preventive action (CAPA) system may be generated in-house, but in many cases key data will come from sources, such as suppliers or contract manufacturers. So companies must ensure that suppliers have CAPA processes that align with the client company. Read More
In a momentous court decision for a failed diagnostic test developer, Elizabeth Holmes, former CEO of Theranos was convicted on four counts of defrauding investors in the U.S. District Court for the Northern District of California on Monday. Read More
Manufacturers must submit a Medical Device Report (MDR) either within 30 days of becoming aware of an adverse event or, in the case of possible “unreasonable risk of substantial harm to the public health,” within five days of learning about the event. Read More
A federal court has rejected Sanofi’s attempts to reinstate key patents covering a drug-device combination product dispensing its insulin blockbuster Lantus. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) has reclassified several class III devices, rated as highest-risk, to the lower-risk class II category. Read More
Zynex has acquired Kestrel Labs for $31 million, adding the Boulder, Colo.-based company’s laser-based, noninvasive patient monitoring technology to its line of noninvasive devices for pain management and monitoring. Read More
Whatever ground the device industry lost due to the COVID-19 pandemic it has mostly regained, according to GlobalData, a UK-based market analytics company. Read More