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In the latest effort to clean up India’s troubled clinical trial industry, the government is requiring that clinical investigators video record the informed consent process with each study subject. Read More
Advisors to Ministry of Health and Family Welfare are calling for reforms to address weaknesses in India’s clinical investigation and medical products approval processes. Read More
In vitro diagnostics products meant for research or investigational use used commercially without appropriate approvals may be considered adulterated and misbranded, an FDA final guidance says. Read More
Washington, D.C.-based MedStar Health has signed a deal licensing to InnoVital Systems the intellectual property rights to the artificial muscle technology that it hopes will power the InVent diaphragm assist device. Read More
Sitoa Global and the University of California San Francisco have signed a letter of intent to negotiate an option agreement for the license of a stereotactic device to deliver stem cells directly into the brain. Read More
The China Food and Drug Administration has published a list of roughly 130 Class II devices that are exempt from submitting clinical trial data. Read More
Medical devicemakers should avoid recruiting and putting at risk an unnecessarily large number of patients in clinical trials, the UK’s Medicines and Healthcare products Regulatory Agency says in one of five trial-related guidances issued last month. Read More
Makers of in vitro diagnostics meant for research or investigational use only should take care not to encourage commercial use of their products. Read More
French medical devicemaker Carmat hopes to wrap up clinical studies of its artificial heart in Europe in time for a 2015 launch date — with eyes on U.S. market entry sometime thereafter. Read More
A federal court in California has ruled that using conventional diagnostic techniques in concert with a natural phenomenon does not add enough to make the end product patent-eligible. Read More
CardioInsight, an Ohio-based devicemaker specializing in mapping abnormal heart rhythms, has secured $15 million in long-term strategic financing for its noninvasive ECVUE monitoring system. Read More