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Mega Electronics, maker of the FemiScan Home Trainer incontinence device and the ME6000 biomonitor device, received an FDA warning letter for incoming inspection shortfalls and other quality issues. Read More
Devicemakers using material from animals that could carry transmissible spongiform encephalopathies should document the absence of TSE disease and standard vaccinations, such as live modified viruses, that the animal received, an updated FDA guidance says. Read More
The U.S. Supreme Court Wednesday unanimously ruled that patent holders must prove infringement, even in cases where a licensee initiated the litigation. Read More
Vietnam’s Ministry of Health has issued a decree specifying requirements for the manufacture, sale, services, information and advertising of medical devices. Read More
Even as more and more healthcare is moving into the home, manufacturers and other stakeholders remain ill-prepared to serve that patient population. Read More